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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 50 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650416
The ClinicalTrials.gov registry entry for NCT00650416 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 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 Carvedilol Tablets 12.5 mg is the first listed.
NCT00650416 reports 0 study locations.
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.
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