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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00830219 | The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions | PHASE1 | COMPLETED | 46 | — | — | Nov 1, 2004 | Nov 1, 2004 | Sep 15, 2009 | 1 | United States |
| NCT00829504 | Ropinirole 0.25 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 44 | — | — | Oct 1, 2004 | Oct 1, 2004 | Sep 11, 2009 | 1 | United States |
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ropinirole HCl 0.25 mg Tablets | DRUG | 1 x 0.25 mg, single dose fed |
| Requip® 0.25 mg Tablets | DRUG | 1 x 0.25 mg, single dose fed |
Inclusion Criteria: * Males and females, 18 to 45 years of age (inclusive), with a body mass index (BMI) of 19-30 kg/m² inclusive and weighing at least 120 lbs. * Sitting (at least 5 minutes) blood pressure of at least 100/70 and sitting pulse of at least 60 b.p.m. * Good health as determined by la...