Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)

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

2009-06-30

Study Completion Date

2009-07-31

Brief Summary

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To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a 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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Arm A

Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions

Group Type OTHER

Saxagliptin

Intervention Type DRUG

Tablet, Oral, 2.5 mg, Once Daily, 1 week

Metformin IR (glucophage)

Intervention Type DRUG

Tablets, Oral, 1000 mg, Once Daily, 1 week

Arm B

Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions

Group Type OTHER

Saxagliptin + Metformin IR (FDC)

Intervention Type DRUG

Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week

Arm C

Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal

Group Type OTHER

Saxagliptin

Intervention Type DRUG

Tablet, Oral, 2.5 mg, Once Daily, 1 week

Metformin IR (glucophage)

Intervention Type DRUG

Tablets, Oral, 1000 mg, Once Daily, 1 week

Arm D

Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal

Group Type OTHER

Saxagliptin + Metformin IR (FDC)

Intervention Type DRUG

Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week

Interventions

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Saxagliptin

Tablet, Oral, 2.5 mg, Once Daily, 1 week

Intervention Type DRUG

Metformin IR (glucophage)

Tablets, Oral, 1000 mg, Once Daily, 1 week

Intervention Type DRUG

Saxagliptin + Metformin IR (FDC)

Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week

Intervention Type DRUG

Other Intervention Names

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Onglyza Glucophage Onglyza Glucophage

Eligibility Criteria

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Inclusion Criteria

* Men and women ages 19 to 45 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

* Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* 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 Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds
* 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 \< 80ml/min using the Cockcroft Gault formula

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes