Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: saxagliptin + metformin (FDC tablet); Drug: metformin; Drug: saxagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068743

CV181-121

Details and patient eligibility

About

To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed condition.

Enrollment: 24 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/m^2, 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 to a dipeptidyl peptidase-IV (DPP4) inhibitor or related compound
• History of allergy or intolerance to metformin or other similar acting agents
• Prior exposure to saxagliptin
• Prior exposure to metformin within 3 months of study drug administration
• Estimated creatinine clearance (Clcr) of < 80 mL/min using the Cockcroft Gault formula

Trial design

24 participants in 4 patient groups

Arm A (saxagliptin 2.5 mg + metformin 850 mg; Fasting)

Other group

Description:

A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fasted condition.

Treatment:

Drug: saxagliptin

Drug: metformin

Arm B (saxagliptin 2.5 mg + metformin 850 mg FDC; Fasting)

Other group

Description:

A single oral dose of 2.5-mg saxagliptin/850-mg metformin fixed dose combination (FDC) administered in the fasted condition.

Treatment:

Drug: saxagliptin + metformin (FDC tablet)

Arm C (saxagliptin 2.5 mg + metformin 850 mg; Fed)

Other group

Description:

A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fed condition.

Treatment:

Drug: saxagliptin

Drug: metformin

Arm D (saxagliptin 2.5 mg + metformin 850 mg FDC; Fed)

Other group

Description:

A single oral dose of 2.5-mg saxagliptin/850-mg metformin FDC administered in the fed condition.

Treatment:

Drug: saxagliptin + metformin (FDC tablet)