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Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

NCT ID: NCT00929201

Last Updated: 2015-08-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.

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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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sita + Met then Sita/Met FDC

Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.

Group Type ACTIVE_COMPARATOR

Sitagliptin phosphate/metformin hydrochloride FDC

Intervention Type DRUG

Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.

Sitagliptin phosphate

Intervention Type DRUG

Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Metformin hydrochloride

Intervention Type DRUG

Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Sita/Met FDC then Sita + Met

Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.

Group Type ACTIVE_COMPARATOR

Sitagliptin phosphate/metformin hydrochloride FDC

Intervention Type DRUG

Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.

Sitagliptin phosphate

Intervention Type DRUG

Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Metformin hydrochloride

Intervention Type DRUG

Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Interventions

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Sitagliptin phosphate/metformin hydrochloride FDC

Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.

Intervention Type DRUG

Sitagliptin phosphate

Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Intervention Type DRUG

Metformin hydrochloride

Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* is in good health
* is a nonsmoker
* is willing to follow all study guidelines

Exclusion Criteria

* has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant
* is a nursing mother
* is unwilling to consume the required high-fat breakfast
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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MK-0431A-080

Identifier Type: OTHER

Identifier Source: secondary_id

2009_607

Identifier Type: OTHER

Identifier Source: secondary_id

0431A-080

Identifier Type: -

Identifier Source: org_study_id

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