Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in Evansville, Indiana) in the fed state in healthy subjects.

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Detailed Description

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This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/1000 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin tablet plus 2 x 500 mg Glucophage XR tablets (manufactured in Evansville, Indiana)

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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5 mg saxagliptin + 2 Glucophage XR 500 mg tablet

Group Type EXPERIMENTAL

saxagliptin

Intervention Type DRUG

Tablets, Oral, 5 mg, once daily, Single dose

Glucophage XR

Intervention Type DRUG

Tablets, Oral, 500 mg, once daily, Single dose

FDC tablet (5 mg saxa + 1000 mg metformin XR) (single dose)

under fed state, single dose

Group Type EXPERIMENTAL

saxagliptin + metformin XR (FDC tablet)

Intervention Type DRUG

Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days

FDC tablet (5 mg saxa + 1000 mg metformin XR) (4 days)

under fed state, 4 days

Group Type EXPERIMENTAL

saxagliptin + metformin XR (FDC tablet)

Intervention Type DRUG

Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days

Interventions

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saxagliptin

Tablets, Oral, 5 mg, once daily, Single dose

Intervention Type DRUG

Glucophage XR

Tablets, Oral, 500 mg, once daily, Single dose

Intervention Type DRUG

saxagliptin + metformin XR (FDC tablet)

Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days

Intervention Type DRUG

Other Intervention Names

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Onglyza Onglyza

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m², inclusive
* Ages 18 to 55, inclusive

Exclusion Criteria

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
* Major surgical procedure within 4 weeks prior to randomization
* Positive serology test for HIV, HBV or HCV
* Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease
* History of gastrointestinal disease within the past 3 months
* Any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator
* Donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization
* Unable to tolerate oral and/or intravenous (IV) medications
* Unable to tolerate the puncturing of veins for drawing of blood
* Known allergy or hypersensitivity to any component of the study medication
* History of any significant drug allergies (such as anaphylaxis or hepatotoxicity)
* Used any prescription drugs or over the counter products to control acid (for example, Prevacid, Mylanta or Rolaids) within 4 weeks prior to randomization
* Used any other drugs including over the counter medications and herbal preparations within 1 week prior to randomization
* Taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes