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NCT00648271 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target
1
Study location

NCT00648271: Completed Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

NCT00648271 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 19 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00648271, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target
1
Study location

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 Studied

Interventions

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

Study Locations (1)

West Virginia

  • Kendle International Inc. - Morgantown

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2002-12
Est. Completion 2003-01
Phase Phase 1
Mylan Pharmaceuticals

146 total trials

What the finished NCT00648271 record still lists

NCT00648271 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Metoprolol Tartrate Tablets 25 mg is the first listed.

NCT00648271 reports a single indexed study location in West Virginia.

Frequently Asked Questions

What is clinical trial NCT00648271 about?

NCT00648271 is a clinical study titled "Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mg". 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.

What is the current status of trial NCT00648271?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2002-12. Estimated completion is 2003-01.

What conditions does trial NCT00648271 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00648271?

The interventions under investigation include: Metoprolol Tartrate Tablets 25 mg (DRUG), Lopressor® Tablets 50 mg (DRUG).

Who is sponsoring clinical trial NCT00648271?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00648271 being conducted?

This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00648271's enrollment target sits among peer trials

19 898th of 1090 higher than 188 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00648271, the US trial registry maintained by the National Library of Medicine. NCT00648271 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.