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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02072954 | Bioequivalence Fasting Study in Patients | PHASE2 | COMPLETED | 48 | — | — | Nov 1, 2013 | Jun 1, 2014 | Jun 27, 2014 | 2 | India |
The area under plasma concentration versus time curve, over the steady state dosing interval, calculated using linear trapezoidal method.
Maximum measured plasma concentration over the steady state doing interval
| Arm | Type | Description |
|---|---|---|
| Asenapine Sublingual Tablets | EXPERIMENTAL | Asenapine Sublingual Tablets, 10 mg. Twice daily for a period of 7 days |
| Saphris Subligual Tablets | ACTIVE_COMPARATOR | Asenapine Sublingual Tablets, 10 mg. Twice daily for 2 periods of 7 days each. |
| Name | Type | Description |
|---|---|---|
| Asenapine Sublingual Tablets 10 mg | DRUG | White to off-white, round, uncoated,unscored, flat-faced radius edge tablet. Debossed with A on one side and 17 on the other side |
Inclusion Criteria: * Adult patients of either sex with age between 18 to 65 years (both inclusive) and have been taking a stable dose of asenapine maleate sublingual tablet, EQ 10 mg base twice daily therapy for at least three months. * Willing and able to comply with study visit schedule and othe...