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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01627834 | Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fasting Condition | PHASE1 | COMPLETED | 48 | — | — | Oct 1, 2009 | Nov 1, 2009 | Sep 28, 2012 | 1 | India |
| NCT01627847 | Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition | PHASE1 | COMPLETED | 48 | — | — | Oct 1, 2009 | Nov 1, 2009 | Sep 28, 2012 | 1 | India |
| Arm | Type | Description |
|---|---|---|
| Ropinirole | EXPERIMENTAL | Ropinirole Hydrochloride ER tablets 2 mg of Dr. Reddy's Laboratories Limited |
| Requip | ACTIVE_COMPARATOR | Requip XL Tablets 2 mg of Glaxosmithkline, USA |
| Name | Type | Description |
|---|---|---|
| Ropinirole | DRUG | - |
Inclusion Criteria: 1. Healthy human subjects aged between 18 and 45 years (including both). 2. Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 45 Kgs. 3. Subjects with normal health as determined by personal medical history, clinical examination, and la...