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NCT00650312 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00650312: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00650312 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650312, 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 is to investigate the bioequivalence of Mylan metformin hydrochloride ER tablets to Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.
Interventions
- DRUG Metformin Hydrochloride ER Tablets 500 mg
- DRUG Glucophage® XR Tablets 500 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2002-10 |
| Est. Completion | 2002-11 |
| Phase | Phase 1 |
What the finished NCT00650312 record still lists
NCT00650312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin Hydrochloride ER Tablets 500 mg is the first listed.
NCT00650312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00650312 about?
NCT00650312 is a clinical study titled "Fasting Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg". The objective of this study is to investigate the bioequivalence of Mylan metformin hydrochloride ER tablets to Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.
What is the current status of trial NCT00650312?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2002-10. Estimated completion is 2002-11.
What interventions are being tested in trial NCT00650312?
The interventions under investigation include: Metformin Hydrochloride ER Tablets 500 mg (DRUG), Glucophage® XR Tablets 500 mg (DRUG).
Who is sponsoring clinical trial NCT00650312?
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 NCT00650312's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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