Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions
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.
Description
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
Conditions
Healthy
Intervention
Pramipexole Dihydrochloride, Pramipexole Dihydrochloride
Location
PRACS Institute, Ltd.
Fargo
North Dakota
United States
58104
Status
Completed
Source
Teva Pharmaceuticals USA
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01074450
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:15:42-0400
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