NCT00648271

Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mg

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metoprolol Tartrate Tablets 25 mg	2x50mg, single dose fed
DRUG	Lopressor® Tablets 50 mg	1x50mg, single dose fed

Timeline

• Start date: 2002-12-01
• Primary completion: 2002-12-01
• Completion: 2003-01-01
• First posted: 2008-04-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States