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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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00649987 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2005-09 |
| Est. Completion | 2005-10 |
| Phase | Phase 1 |
What the finished NCT00649987 record still lists
NCT00649987 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 Tablets 8 mg is the first listed.
NCT00649987 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00649987'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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