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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 50 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650312
The ClinicalTrials.gov registry entry for NCT00650312 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 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.
NCT00650312 reports 0 study locations.
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.
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