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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-03-31

Brief Summary

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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.

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

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.

Group Type OTHER

saxagliptin

Intervention Type DRUG

Tablets, Oral, 2.5 mg, once daily, single dose

metformin

Intervention Type DRUG

Tablets, Oral, 850 mg, once daily, single dose

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

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

Group Type OTHER

saxagliptin + metformin (FDC tablet)

Intervention Type DRUG

Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose

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

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.

Group Type OTHER

saxagliptin

Intervention Type DRUG

Tablets, Oral, 2.5 mg, once daily, single dose

metformin

Intervention Type DRUG

Tablets, Oral, 850 mg, once daily, single dose

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

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

Group Type OTHER

saxagliptin + metformin (FDC tablet)

Intervention Type DRUG

Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose

Interventions

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saxagliptin

Tablets, Oral, 2.5 mg, once daily, single dose

Intervention Type DRUG

metformin

Tablets, Oral, 850 mg, once daily, single dose

Intervention Type DRUG

saxagliptin + metformin (FDC tablet)

Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose

Intervention Type DRUG

Other Intervention Names

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Onglyza Glucophage

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/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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes