Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
risperidone · 1 trial · 1 indication
An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug. A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] AUC0-24 calculated using the linear trapezoidal rule. Results are reported across two timeframes: * Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection) * Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Cmax determined directly from individual concentration-time data. Results are reported across two timeframes: * Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection) * Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Tmax determined directly from individual concentration-time data. Results are reported across two timeframes: * Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection) * Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] AUCtau calculated using the linear trapezoidal rule. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days) Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Maximum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Minimum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days. The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1. The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 at time of study drug administration.
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Maximum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Minimum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone: * \[Total Risperidone\] = \[Risperidone\] + (410/426) \* \[9-hydroxyrisperidone\] Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
AUC0-24 calculated using the linear trapezoidal rule. Results are reported across two timeframes: * Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection) * Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Cmax determined directly from individual concentration-time data. Results are reported across two timeframes: * Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection) * Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Tmax determined directly from individual concentration-time data. Results are reported across two timeframes: * Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection) * Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
AUCtau calculated using the linear trapezoidal rule. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days) Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Maximum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Minimum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days. The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1. The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Maximum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Minimum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
AUC0-24 calculated using the linear trapezoidal rule. Results are reported across two timeframes: * Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection) * Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Cmax determined directly from individual concentration-time data. Results are reported across two timeframes: * Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection) * Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Tmax determined directly from individual concentration-time data. Results are reported across two timeframes: * Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection) * Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
AUCtau calculated using the linear trapezoidal rule. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days) Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Maximum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Minimum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin. Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Results are reported across two timeframes: * Overall, Injection 1 (Day 1 injection to Day 28) * Overall, Injection 3 (Day 57 injection to Day 84) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days. The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1. The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Maximum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Minimum plasma concentrations determined directly from individual concentration-time data. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin. Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Results are reported across two timeframes: * Secondary Peak, Injection 1 (Day 2 - Day 29) * Secondary Peak, Injection 3 (Day 58 - Day 85) The PK sampling schedule was: * Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose * Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
| Arm | Type | Description |
|---|---|---|
| Cohort 1, RBP-7000 60 mg | EXPERIMENTAL | Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87. |
| Cohort 2, RBP-7000 90 mg | EXPERIMENTAL | Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87. |
| Cohort 3, RBP-7000 120 mg | EXPERIMENTAL | Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87. |
| Name | Type | Description |
|---|---|---|
| Risperidone | DRUG | Oral risperidone was supplied as 2, 3, or 4 mg tablets in blister packs or bottles and taken daily only during the oral dosing periods of the study, days -14 through -8 (if applicable), days -7 through -1, and days 85 through 87. |
| RBP-7000 | DRUG | RBP-7000 60 mg, 90 mg, and 120 mg were a mixture of the ATRIGEL® Delivery System and 60 mg, 90 mg, or 120 mg risperidone, respectively. Treatment was delivered as subcutaneous injections on study days 1, 29 and 57. |
Inclusion Criteria: * Male and female * \> 18 to \< 65 years * Diagnosis of paranoid, residual, or undifferentiated schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria * Status: clinically stable subjects defined as subjects wit...