Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults under fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms:
arm 1: Pramipexole Dihydrochloride 0.25 mg Tablets arm 2: Mirapex® 0.25 mg Tablets

Interventions: intervention 1: Pramipexole Dihydrochloride intervention 2: Pramipexole Dihydrochloride
Intervention descriptions: intervention 1: 0.25 mg Tablet intervention 2: 0.25 mg Tablet

Protocol document: