# A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects

> **NCT02637037** · PHASE1 · COMPLETED · sponsor: **AstraZeneca** · enrollment: 80 (actual)

## Conditions studied

- Bioequivalence
- Fixed Dose Combination Tablets
- Healthy Male and Female Subjects

## 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)

## Key facts

- **NCT ID:** NCT02637037
- **Lead sponsor:** AstraZeneca
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-12-21
- **Primary completion:** 2016-04-07
- **Final completion:** 2016-04-07
- **Target enrollment:** 80 (ACTUAL)
- **Last updated:** 2018-03-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02637037

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02637037, "A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT02637037. Licensed CC0.

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