NCT00653055

Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions

Randomized, 4-Way Replicate Crossover, Bioequivalence Study of Cabergoline 0.5 mg Tablets and Dostinex 0.5 mg Tablets Administered as 2 x 0.5 mg Tablets in Healthy Adult Females and Males Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Par Pharmaceutical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)

Detailed description

To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference) administered as 2 x 0.5 mg tablets under fasting conditions.

Conditions

• To Determine Bioequivalence Under Fasting Conditions

Interventions

Type	Name	Description
DRUG	Cabergoline	Tablets, 0.5 mg (2 x 0.5 mg dose),fasting
DRUG	Dostinex	Tablets, 0.5 mg (2 x 0.5 mg dose), fasting

Timeline

• Start date: 2001-08-01
• Primary completion: 2001-12-01
• Completion: 2001-12-01
• First posted: 2008-04-04
• Last updated: 2008-04-04

Locations

1 site across 1 country: Canada