Bioequivalence Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly

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Detailed Description

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Primary Purpose:

Other: Protocol designed to demonstrate the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana and the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana in healthy human subjects under fed conditions

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)

Saxagliptin 5 mg /Metformin 1000 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day 1 of Periods 1 and 2

Group Type EXPERIMENTAL

Saxagliptin/Metformin

Intervention Type DRUG

Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon)

Saxagliptin 5 mg/Metformin 1000 mg (Mt. Vernon) tablet by mouth once daily on Day 1 of Periods 1 and 2

Group Type EXPERIMENTAL

Saxagliptin/Metformin

Intervention Type DRUG

Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)

Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day1 of Periods 1 and 2

Group Type EXPERIMENTAL

Saxagliptin/Metformin

Intervention Type DRUG

Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon)

Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon) tablet by mouth once daily Day 1 of Periods 1 and 2

Group Type EXPERIMENTAL

Saxagliptin/Metformin

Intervention Type DRUG

Interventions

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Saxagliptin/Metformin

Intervention Type DRUG

Other Intervention Names

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Kombiglyze XR

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects, 18-45 years of age
* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive
* Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product

Exclusion Criteria

* Any significant acute or chronic medical illness
* Estimated creatinine clearance of \<60 mL/min as calculated using the Modification of Diet in Renal Disease method Current or recent (within 3 months of study drug administration)
* Gastrointestinal (GI) disease that could affect the absorption of study drug
* Inability to tolerate oral medication
* History of allergies or adverse reactions to DPP4 inhibitors or Metformin or related compounds
* Current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes