Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions

2014-08-27 03:15:42 | BioPortfolio


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.


Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label




Pramipexole Dihydrochloride, Pramipexole Dihydrochloride


PRACS Institute, Ltd.
North Dakota
United States




Teva Pharmaceuticals USA

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:42-0400

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