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NCT00649779 · ClinicalTrials.gov registry record · Phase 1

Fasting 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

NCT00649779: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.

NCT00649779 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00649779, 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 fasting conditions.

Interventions

  • DRUG albuterol sulfate extended-release 8 mg tablets
  • DRUG VoSpire™ ER 8 mg tablets

Trial Details

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

146 total trials

What the finished NCT00649779 record still lists

NCT00649779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 2 interventions - of which albuterol sulfate extended-release 8 mg tablets is the first listed.

NCT00649779 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00649779 about?

NCT00649779 is a clinical study titled "Fasting 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 fasting conditions.

What is the current status of trial NCT00649779?

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 NCT00649779?

The interventions under investigation include: albuterol sulfate extended-release 8 mg tablets (DRUG), VoSpire™ ER 8 mg tablets (DRUG).

Who is sponsoring clinical trial NCT00649779?

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

How this trial's enrollment target compares

Where NCT00649779's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00649779, the US trial registry maintained by the National Library of Medicine. NCT00649779 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.