# Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)

> **NCT01192139** · PHASE1 · COMPLETED · sponsor: **AstraZeneca** · enrollment: 30 (actual)

## Conditions studied

- Diabetes Mellitus

## Interventions

- **DRUG:** saxagliptin
- **DRUG:** metformin XR
- **DRUG:** saxagliptin + metformin XR (FDC tablet)

## Key facts

- **NCT ID:** NCT01192139
- **Lead sponsor:** AstraZeneca
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-11
- **Primary completion:** 2009-12
- **Final completion:** 2009-12
- **Target enrollment:** 30 (ACTUAL)
- **Last updated:** 2015-05-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01192139

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01192139, "Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01192139. Licensed CC0.

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