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NCT00649987 · ClinicalTrials.gov registry record · Phase 1

Fed Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT00649987 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 21 participants.

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The verdict

NCT00649987, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

The objective of this study was to investigate the bioequivalence of Mylan's albuterol sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.

Interventions

  • DRUG Albuterol Sulfate Extended-Release Tablets 8 mg
  • DRUG VoSpire® ER Tablets 8 mg

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2005-09
Est. Completion 2005-10
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00649987

The ClinicalTrials.gov registry entry for NCT00649987 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Albuterol Sulfate Extended-Release Tablets 8 mg is the first listed.

NCT00649987 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00649987 about?

NCT00649987 is a clinical study titled "Fed Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg". The objective of this study was to investigate the bioequivalence of Mylan's albuterol sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.

What is the current status of trial NCT00649987?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2005-09. Estimated completion is 2005-10.

What interventions are being tested in trial NCT00649987?

The interventions under investigation include: Albuterol Sulfate Extended-Release Tablets 8 mg (DRUG), VoSpire® ER Tablets 8 mg (DRUG).

Who is sponsoring clinical trial NCT00649987?

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

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

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, or report a data error.