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NCT00650416 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00650416: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00650416 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650416, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5 mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x 12.5 mg) dose administered under fasting conditions.
Interventions
- DRUG Carvedilol Tablets 12.5 mg
- DRUG Coreg® Tablets 12.5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2004-03 |
| Est. Completion | 2004-04 |
| Phase | Phase 1 |
What the finished NCT00650416 record still lists
NCT00650416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Carvedilol Tablets 12.5 mg is the first listed.
NCT00650416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00650416 about?
NCT00650416 is a clinical study titled "Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg". The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5 mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x 12.5 mg) dose administered under fasting conditions.
What is the current status of trial NCT00650416?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2004-03. Estimated completion is 2004-04.
What interventions are being tested in trial NCT00650416?
The interventions under investigation include: Carvedilol Tablets 12.5 mg (DRUG), Coreg® Tablets 12.5 mg (DRUG).
Who is sponsoring clinical trial NCT00650416?
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 NCT00650416's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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