A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)

NCT ID: NCT00961480

Last Updated: 2015-06-09

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-11-30

Brief Summary

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A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).

Detailed Description

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Conditions

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Type 2 Diabetes

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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Treatment A

50 mg sitagliptin and 500 mg metformin as individual tablets

Group Type ACTIVE_COMPARATOR

sitagliptin phosphate (+) metformin hydrochloride

Intervention Type DRUG

place holder - do not post

Comparator: metformin 500mg

Intervention Type DRUG

A single dose of metformin 500 mg tablet

Comparator: sitagliptin

Intervention Type DRUG

A single dose of 50 mg sitagliptin tablet

Treatment B

sitagliptin/metformin 50 mg/500 mg tablet

Group Type EXPERIMENTAL

Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet

Intervention Type DRUG

A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet

Treatment C

50 mg sitagliptin and 1000 mg metformin as individual tablets

Group Type ACTIVE_COMPARATOR

Comparator: sitagliptin

Intervention Type DRUG

A single dose of 50 mg sitagliptin tablet

Comparator: metformin 1000 mg

Intervention Type DRUG

A single dose of metformin 1000 mg tablet

Treatment D

sitagliptin/metformin 50 mg/1000 mg tablet

Group Type EXPERIMENTAL

Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

Intervention Type DRUG

A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

Treatment E

50 mg sitagliptin and 850 mg metformin as individual tablets

Group Type ACTIVE_COMPARATOR

Comparator: sitagliptin

Intervention Type DRUG

A single dose of 50 mg sitagliptin tablet

Comparator: metformin 850 mg

Intervention Type DRUG

A single dose of metformin 850 mg tablet

Treatment F

sitagliptin/metformin 50 mg/850 mg tablet

Group Type EXPERIMENTAL

Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

Intervention Type DRUG

A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

Interventions

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sitagliptin phosphate (+) metformin hydrochloride

place holder - do not post

Intervention Type DRUG

Comparator: metformin 500mg

A single dose of metformin 500 mg tablet

Intervention Type DRUG

Comparator: sitagliptin

A single dose of 50 mg sitagliptin tablet

Intervention Type DRUG

Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet

A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet

Intervention Type DRUG

Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

Intervention Type DRUG

Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

Intervention Type DRUG

Comparator: metformin 1000 mg

A single dose of metformin 1000 mg tablet

Intervention Type DRUG

Comparator: metformin 850 mg

A single dose of metformin 850 mg tablet

Intervention Type DRUG

Other Intervention Names

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Glucophage Januvia Glucophage Glucophage

Eligibility Criteria

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Inclusion Criteria

* Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception
* Subject is in good health and is a non-smoker

Exclusion Criteria

* Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder
* Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Subject is a nursing mother
* Subject consumes excessive amounts of alcohol or caffeine
* Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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 Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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MK0431A-095

Identifier Type: -

Identifier Source: secondary_id

2009_636

Identifier Type: -

Identifier Source: secondary_id

0431A-095

Identifier Type: -

Identifier Source: org_study_id

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