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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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00648518 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00648518 record still lists
NCT00648518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin Hydrochloride ER Tablets 750 mg is the first listed.
NCT00648518 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00648518's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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