MedTrace Logo

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

NCT00648271 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-04-23

No results posted yet for this study

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

DRUG

Metoprolol Tartrate Tablets 25 mg

2x50mg, single dose fed

DRUG

Lopressor® Tablets 50 mg

1x50mg, single dose fed

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Thomas S Clark, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2002-12-31
Completion
2003-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00648271 on ClinicalTrials.gov