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NCT00648518 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Metformin Hydrochloride ER Tablets 750 mg and Glucophage® XR Tablets 750 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00648518 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants.
The verdict
NCT00648518, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 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 750 mg (1 x 750 mg) dose administered under fasting conditions.
Interventions
- DRUG Metformin Hydrochloride ER Tablets 750 mg
- DRUG Glucophage® XR Tablets 750 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2003-12 |
| Est. Completion | 2003-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648518
The ClinicalTrials.gov registry entry for NCT00648518 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 750 mg is the first listed.
NCT00648518 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00648518 about?
NCT00648518 is a clinical study titled "Fasting Study of Metformin Hydrochloride ER Tablets 750 mg and Glucophage® XR Tablets 750 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 750 mg (1 x 750 mg) dose administered under fasting conditions.
What is the current status of trial NCT00648518?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2003-12. Estimated completion is 2003-12.
What interventions are being tested in trial NCT00648518?
The interventions under investigation include: Metformin Hydrochloride ER Tablets 750 mg (DRUG), Glucophage® XR Tablets 750 mg (DRUG).
Who is sponsoring clinical trial NCT00648518?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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