NCT00652873

Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

Randomized, 2-Way 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 Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 fed conditions.

Conditions

• To Determine Bioequivalence Under Fed Conditions

Interventions

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

Timeline

• Start date: 2001-07-01
• Primary completion: 2001-12-01
• Completion: 2001-12-01
• First posted: 2008-04-04
• Last updated: 2017-09-26

Locations

1 site across 1 country: Canada