Single-Dose Food In Vivo Bioequivalence Study of Metoprolol Tartrate Tablets (25 mg; Mylan) and Lopressor® (50 mg; Novartis) in Healthy Volunteers

NCT00648271 Phase 1 COMPLETED

The objective of this study was to investigate the bioequivalence of Mylan's metoprolol tartrate tablets to Novartis' Lopressor® tablets following a single, oral 50 mg (2 x 25 mg tablets for Mylan's formulation and 1 x 50 mg for Lopressor®) dose administered under fed conditions.

Details

Lead sponsor	Mylan Pharmaceuticals Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	19
Start date	2002-12
Completion	2003-01

Conditions

• Healthy

Interventions

• Metoprolol Tartrate Tablets 25 mg
• Lopressor® Tablets 50 mg

Primary outcomes

• Bioequivalence — within 30 days

Countries

United States