NCT00650520

Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets

Study of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets Following a 10 mg Dose in Healthy Adult Volunteers Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg bromocriptine mesylate tablets, following the administration of a 10 mg dose, under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg	4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
DRUG	Parlodel® (bromocriptine mesylate) capsules, USP 5 mg	4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: Canada