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NCT00835497 · ClinicalTrials.gov registry record · Phase 1
5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00835497: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00835497 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835497, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult subjects administered under fasting conditions.
Primary Outcome
Bioequivalence based on Cmax
Interventions
- DRUG 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets
- DRUG 5 mg/500 mg METAGLIP™ Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-06 |
| Est. Completion | 2004-06 |
| Phase | Phase 1 |
What the finished NCT00835497 record still lists
NCT00835497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets is the first listed.
NCT00835497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00835497 about?
NCT00835497 is a clinical study titled "5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting". This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg METAGLIP™ Tablets by Bristol-Myers ...
What is the current status of trial NCT00835497?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2004-06. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00835497?
The interventions under investigation include: 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets (DRUG), 5 mg/500 mg METAGLIP™ Tablets (DRUG).
Who is sponsoring clinical trial NCT00835497?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00835497's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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