Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pramipexole · 2 trials · 1 indication
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...
Pramipexole is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical trials, studied in healthy volunteers to assess the effects of Pramipexole Dihydrochloride 0.25 mg tablets under fasting and non-fasting conditions.
Pramipexole is developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker symbol TEVA. The drug is currently in Phase 1 clinical development.
Pramipexole is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy volunteers to evaluate the pharmacokinetics of Pramipexole Dihydrochloride 0.25 mg tablets.
Pramipexole has two completed Phase 1 clinical trials: NCT01074450, studying the drug under fasting conditions, and NCT01074463, studying it under non-fasting conditions. Both trials enrolled 24 healthy volunteers each in the United States, with a minimum age of 18 years.
Pramipexole is the active ingredient in the drug product Pramipexole Dihydrochloride. The clinical trials for Pramipexole use the dihydrochloride salt form, administered as 0.25 mg tablets.