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NCT00650299 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Alprazolam Extended-release Tablets 3 mg to Xanax XR® Tablets 3 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00650299 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 21 participants.
The verdict
NCT00650299, 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 alprazolam Extended-release 3 mg tablets to Pharmacia \& Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered under fed conditions.
Interventions
- DRUG Alprazolam Extended-release Tablets 3 mg
- DRUG Xanax XR® Tablets 3 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2004-08 |
| Est. Completion | 2004-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650299
The ClinicalTrials.gov registry entry for NCT00650299 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 Alprazolam Extended-release Tablets 3 mg is the first listed.
NCT00650299 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00650299 about?
NCT00650299 is a clinical study titled "Fed Study of Alprazolam Extended-release Tablets 3 mg to Xanax XR® Tablets 3 mg". The objective of this study was to investigate the bioequivalence of Mylan's alprazolam Extended-release 3 mg tablets to Pharmacia \& Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered under fed conditions.
What is the current status of trial NCT00650299?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2004-08. Estimated completion is 2004-08.
What interventions are being tested in trial NCT00650299?
The interventions under investigation include: Alprazolam Extended-release Tablets 3 mg (DRUG), Xanax XR® Tablets 3 mg (DRUG).
Who is sponsoring clinical trial NCT00650299?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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