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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01101464 | A Trial to Determine Whether Two Differing Strength Tablets (3 x 5 mg Versus 1 x 15 mg) of Sublingually Org 5222 (Asenapine) Are Safe and Equal in Subjects With Schizophrenia or Schizoaffective Disorder (P05937) | PHASE2 | COMPLETED | 8 | — | — | Oct 1, 2002 | Dec 1, 2002 | Feb 9, 2022 | - | — |
The primary objective is to compare the bioavailability using pharmacokinetic parameter of maximum plasma concentration (Cmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222 Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.
The primary objective is to compare the bioavailability using pharmacokinetic parameter of time of occurrence of Cmax (Tmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222. Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2
The primary objective is to compare the bioavailability using pharmacokinetic parameter of area under the curve (AUC) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222. Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.
| Arm | Type | Description |
|---|---|---|
| Asenapine Sequence 1 | EXPERIMENTAL | - |
| Asenapine Sequence 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Asenapine 3x5mg followed by 1x15mg | DRUG | Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days |
| Asenapine 1x15mg followed by 3x5mg | DRUG | One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days. |
Inclusion Criteria: * must provide written informed consent after the scope and nature of the investigation has been explained to them, but before signing any trial-related activities, including screening evaluations; * must be at least 18 and less than 65 years of age; * can be either male or fema...