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NCT02637037 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT02637037: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02637037 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02637037, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
Primary Outcome
To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state.
Interventions
- DRUG dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)
- DRUG dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)
- DRUG dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
- DRUG dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2015-12-21 |
| Est. Completion | 2016-04-07 |
| Phase | Phase 1 |
What the finished NCT02637037 record still lists
NCT02637037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 4 interventions - of which dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon) is the first listed.
NCT02637037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02637037 about?
NCT02637037 is a clinical study titled "A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects". This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
What is the current status of trial NCT02637037?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2015-12-21. Estimated completion is 2016-04-07.
What interventions are being tested in trial NCT02637037?
The interventions under investigation include: dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon) (DRUG), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao) (DRUG), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon) (DRUG), dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao) (DRUG).
Who is sponsoring clinical trial NCT02637037?
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 NCT02637037's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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