Approval Probability
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Also known as Pramipexole Dihydrochloride, Mirapex®
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 developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is being studied in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed.
Pramipexole targets the dopamine receptors DRD2, DRD3, and DRD4. It acts as an agonist at these receptors, meaning it activates them. This mechanism is characteristic of drugs that mimic the action of dopamine in the brain.
Pramipexole is developed by Teva Pharmaceutical Industries Limited, a pharmaceutical company whose shares trade under the ticker symbol TEVA. Teva is responsible for the clinical development of this drug candidate.
Pramipexole is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 trials listed for this drug have been completed.
Pramipexole has been studied in two completed Phase 1 trials: NCT01074463, which evaluated pramipexole dihydrochloride 0.25 mg tablets under non-fasting conditions, and NCT01074450, which evaluated the same tablets under fasting conditions. Both trials enrolled 24 healthy volunteers in the United States.
Yes, Pramipexole Dihydrochloride is an alternative name for Pramipexole. The two names refer to the same active ingredient. The clinical trials for this drug use the dihydrochloride salt form in 0.25 mg tablets.