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NCT01068730 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01068730: Completed Phase 1 study, sponsored by AstraZeneca.
NCT01068730 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01068730, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state
Primary Outcome
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
Interventions
- DRUG metformin (Diabex)
- DRUG metformin (Glucophage™)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-02 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
What the finished NCT01068730 record still lists
NCT01068730 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which metformin (Diabex) is the first listed.
NCT01068730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01068730 about?
NCT01068730 is a clinical study titled "Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects". To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state
What is the current status of trial NCT01068730?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2010-02. Estimated completion is 2010-04.
What interventions are being tested in trial NCT01068730?
The interventions under investigation include: metformin (Diabex) (DRUG), metformin (Glucophage™) (DRUG).
Who is sponsoring clinical trial NCT01068730?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01068730's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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