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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 80 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02637037
The ClinicalTrials.gov registry entry for NCT02637037 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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