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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: metformin (Diabex); Drug: metformin (Glucophage™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068730

CV181-120

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 4 patient groups

Treatment A

Other group

Description:

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

Treatment:

Drug: metformin (Diabex)

Drug: metformin (Diabex)

Treatment B

Other group

Description:

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

Treatment:

Drug: metformin (Glucophage™)

Drug: metformin (Glucophage™)

Treatment C

Other group

Description:

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

Treatment:

Drug: metformin (Diabex)

Drug: metformin (Diabex)

Treatment D

Other group

Description:

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

Treatment:

Drug: metformin (Glucophage™)

Drug: metformin (Glucophage™)