Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-04-30

Brief Summary

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To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Treatment A

500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition

Group Type OTHER

metformin (Diabex)

Intervention Type DRUG

Tablets, Oral, 500 mg, Once daily, single dose

Treatment B

500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition

Group Type OTHER

metformin (Glucophage™)

Intervention Type DRUG

Tablets, Oral, 500 mg, Once Daily, single dose

Treatment C

1000 mg metformin (Diabex): Single oral dose of 1000 mg metformin (Diabex) tablet administered in the fed condition

Group Type OTHER

metformin (Diabex)

Intervention Type DRUG

Tablets, Oral, 1000 mg, Once daily, single dose

Treatment D

1000 mg metformin (Glucophage™): A Single oral dose of 1000 mg metformin (Glucophage™) tablet administered in the fed condition

Group Type OTHER

metformin (Glucophage™)

Intervention Type DRUG

Tablets, Oral, 1000 mg, Once daily, single dose

Interventions

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metformin (Diabex)

Tablets, Oral, 500 mg, Once daily, single dose

Intervention Type DRUG

metformin (Glucophage™)

Tablets, Oral, 500 mg, Once Daily, single dose

Intervention Type DRUG

metformin (Glucophage™)

Tablets, Oral, 1000 mg, Once daily, single dose

Intervention Type DRUG

metformin (Diabex)

Tablets, Oral, 1000 mg, Once daily, single dose

Intervention Type DRUG

Other Intervention Names

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Diabex Glucophage™ Glucophage™ Diabex

Eligibility Criteria

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Inclusion Criteria

* Men and women ages 18 to 55 inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]²

Exclusion Criteria

* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of allergy or intolerance to metformin or other similar acting agents
* Prior exposure to metformin within 3 months of study drug administration
* Estimated creatinine clearance (Clcr) of \< 80ml/min using the Cockcroft Gault formula

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes