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Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

NCT ID: NCT01093794

Last Updated: 2015-07-28

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-06-30

Brief Summary

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This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.

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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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1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

* Co-administration of 50 mg sitagliptin and 500 mg metformin
* sitagliptin/metformin 50 mg/500 mg FDC tablet
* sitagliptin/metformin 50 mg/850 mg FDC tablet
* Co-administration of 50 mg sitagliptin and 850 mg metformin

Group Type EXPERIMENTAL

Co-administration of 50 mg sitagliptin and 500 mg metformin

Intervention Type DRUG

Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.

sitagliptin/metformin 50 mg/500 mg tablet

Intervention Type DRUG

Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

Co-administration of 50 mg sitagliptin and 850 mg metformin

Intervention Type DRUG

Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.

sitagliptin/metformin 50 mg/850 mg tablet

Intervention Type DRUG

Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

* sitagliptin/metformin 50 mg/500 mg FDC tablet
* Co-administration of 50 mg sitagliptin and 850 mg metformin
* Co-administration of 50 mg sitagliptin and 500mg metformin
* sitagliptin/metformin 50 mg/850 mg FDC tablet

Group Type EXPERIMENTAL

Co-administration of 50 mg sitagliptin and 500 mg metformin

Intervention Type DRUG

Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.

sitagliptin/metformin 50 mg/500 mg tablet

Intervention Type DRUG

Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

Co-administration of 50 mg sitagliptin and 850 mg metformin

Intervention Type DRUG

Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.

sitagliptin/metformin 50 mg/850 mg tablet

Intervention Type DRUG

Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

* Co-administration of 50 mg sitagliptin and 850 mg metformin
* sitagliptin/metformin 50 mg/850 mg FDC tablet
* sitagliptin/metformin 50 mg/500 mg FDC tablet
* Co-administration of 50 mg sitagliptin and 500mg metformin

Group Type EXPERIMENTAL

Co-administration of 50 mg sitagliptin and 500 mg metformin

Intervention Type DRUG

Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.

sitagliptin/metformin 50 mg/500 mg tablet

Intervention Type DRUG

Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

Co-administration of 50 mg sitagliptin and 850 mg metformin

Intervention Type DRUG

Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.

sitagliptin/metformin 50 mg/850 mg tablet

Intervention Type DRUG

Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

* sitagliptin/metformin 50 mg/850 mg FDC tablet
* Co-administration of 50 mg sitagliptin and 500 mg metformin
* Co-administration of 50 mg sitagliptin and 850 mg metformin
* sitagliptin/metformin 50 mg/500 mg FDC tablet

Group Type EXPERIMENTAL

Co-administration of 50 mg sitagliptin and 500 mg metformin

Intervention Type DRUG

Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.

sitagliptin/metformin 50 mg/500 mg tablet

Intervention Type DRUG

Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

Co-administration of 50 mg sitagliptin and 850 mg metformin

Intervention Type DRUG

Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.

sitagliptin/metformin 50 mg/850 mg tablet

Intervention Type DRUG

Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

Interventions

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Co-administration of 50 mg sitagliptin and 500 mg metformin

Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.

Intervention Type DRUG

sitagliptin/metformin 50 mg/500 mg tablet

Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

Intervention Type DRUG

Co-administration of 50 mg sitagliptin and 850 mg metformin

Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.

Intervention Type DRUG

sitagliptin/metformin 50 mg/850 mg tablet

Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject is of Chinese descent
* Subject is in good health
* Subject is a non-smoker

Exclusion Criteria

* Subject has a history of stroke or chronic seizures
* Subject has a history of cancer
* Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

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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2010_518

Identifier Type: -

Identifier Source: secondary_id

0431A-122

Identifier Type: -

Identifier Source: org_study_id

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