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NCT00650234 · ClinicalTrials.gov registry record · Phase 1
Fasting BE Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg
A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT00650234: Completed Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
NCT00650234 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 47 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650234, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
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 fasting conditions.
Conditions Studied
Interventions
- DRUG Metformin Hydrochloride ER Tablets 500 mg
- DRUG Glucophage® XR Tablets 500 mg
Study Locations (1)
West Virginia
- Kendle International Inc. - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2004-02 |
| Est. Completion | 2004-03 |
| Phase | Phase 1 |
What the finished NCT00650234 record still lists
NCT00650234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Metformin Hydrochloride ER Tablets 500 mg is the first listed.
NCT00650234 reports a single indexed study location in West Virginia.
Frequently Asked Questions
What is clinical trial NCT00650234 about?
NCT00650234 is a clinical study titled "Fasting BE Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 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 fasting conditions.
What is the current status of trial NCT00650234?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2004-02. Estimated completion is 2004-03.
What conditions does trial NCT00650234 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00650234?
The interventions under investigation include: Metformin Hydrochloride ER Tablets 500 mg (DRUG), Glucophage® XR Tablets 500 mg (DRUG).
Who is sponsoring clinical trial NCT00650234?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00650234 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00650234's enrollment target sits among peer trials
47 490th of 1090 higher than 598 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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