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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

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00648271

The ClinicalTrials.gov registry entry for NCT00648271 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.