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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01074450 | Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Feb 1, 2005 | Mar 1, 2005 | Apr 30, 2010 | 1 | United States |
| NCT01074463 | Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Feb 1, 2005 | Mar 1, 2005 | Apr 30, 2010 | 1 | United States |
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Pramipexole Dihydrochloride 0.25 mg Tablets |
| 2 | ACTIVE_COMPARATOR | Mirapex® 0.25 mg Tablets |
| Name | Type | Description |
|---|---|---|
| Pramipexole Dihydrochloride | DRUG | 0.25 mg Tablet |
Inclusion Criteria: * All volunteers selected for this study will be healthy men and women 18 to 45 years of age, inclusive. * The weight range will not exceed + 20% for height and body frame as per Desirable Weight for Adults - 1983 Metropolitan Height and Weight Table. * Each volunteer will compl...