NCT01074450

Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of 0.25 mg Pramipexole Dihydrochloride Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pramipexole Dihydrochloride	0.25 mg Tablet
DRUG	Pramipexole Dihydrochloride	0.25 mg Tablet

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2010-02-24
• Last updated: 2010-04-30
• Results posted: 2010-04-30

Locations

1 site across 1 country: United States