# Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers

> **NCT01725672** · PHASE1 · TERMINATED · sponsor: **GlaxoSmithKline** · enrollment: 20 (actual)

## Conditions studied

- Diabetes Mellitus, Type 2

## Interventions

- **DRUG:** Metformin, 500 mg extended release tablet
- **DRUG:** Metformin, 1000 mg extended release tablet
- **DRUG:** Glimepiride, 1 mg immediate release tablet
- **DRUG:** Glimepiride, 2 mg immediate release tablet
- **DRUG:** Metformin, 500 mg and Glimepiride, 1 mg extended release film coated tablet containing release controlling polymers
- **DRUG:** Metformin, 1000 mg and Glimepiride, 2 mg extended release film coated tablet containing release controlling polymers
- **DRUG:** Metformin, 500 mg and Glimepiride, 1 mg extended release tablet coated with release controlling polymers
- **DRUG:** Metformin, 1000 mg and Glimepiride, 2 mg extended release tablet coated with release controlling polymers

## Key facts

- **NCT ID:** NCT01725672
- **Lead sponsor:** GlaxoSmithKline
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2012-09-27
- **Primary completion:** 2013-08-21
- **Final completion:** 2013-08-21
- **Target enrollment:** 20 (ACTUAL)
- **Why stopped:** Due to changes in EMA guidelines on modified release dosage forms (Feb 2013; EMA/CHMP/EWP/280/96). The Part B formulation would not meet the new guidelines.
- **Last updated:** 2017-06-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01725672

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01725672, "Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01725672. Licensed CC0.

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