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NCT00649948 · ClinicalTrials.gov registry record · Phase 1
Food BE Study Metformin Hydrochloride ER Tablets 500 mg and Glucophage XR 500 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT00649948 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 27 participants.
The verdict
NCT00649948, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fed conditions.
Interventions
- DRUG Metformin Hydrochloride ER Tablets 500 mg
- DRUG Glucophage XR 500 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2004-02 |
| Est. Completion | 2004-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00649948
The ClinicalTrials.gov registry entry for NCT00649948 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 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 Metformin Hydrochloride ER Tablets 500 mg is the first listed.
NCT00649948 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00649948 about?
NCT00649948 is a clinical study titled "Food BE Study Metformin Hydrochloride ER Tablets 500 mg and Glucophage XR 500 mg". The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fed conditions.
What is the current status of trial NCT00649948?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2004-02. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00649948?
The interventions under investigation include: Metformin Hydrochloride ER Tablets 500 mg (DRUG), Glucophage XR 500 mg (DRUG).
Who is sponsoring clinical trial NCT00649948?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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