Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01761565 | Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab | PHASE1 | COMPLETED | 40 | — | — | Jan 1, 2013 | Feb 1, 2013 | Oct 1, 2015 | 1 | United States |
For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1. For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3
Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p \>0.05)
the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration
| Arm | Type | Description |
|---|---|---|
| Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg | EXPERIMENTAL | Period 1: Single dose of SUF NT 15 mcg Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes |
| Name | Type | Description |
|---|---|---|
| Single dose of SUF NT 15 mcg | DRUG | - |
| 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes | DRUG | - |
Inclusion Criteria: * Non smoking * Ages 18 to 45 year, inclusive * BMI between 18 and 30 Exclusion Criteria: * Subjects taking any prescription or OTC medications or vitamins or supplements * Pregnant females * Subjects with pulmonary disease or sleep apnea