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

Type 2 Diabetes Clinical Trial

Official title:

A Bioequivalence Study With Two Tablet Strengths of the Final Market Image (FMI) Sitagliptin/Metformin Fixed Dose Combination (FDC) Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093794
• Other study ID #: 0431A-122
• Secondary ID: 2010_518
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2010
• Last updated: July 17, 2015
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC(0-t)) for Sitagliptin	AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.	baseline through 72 hours postdose	No
Primary	Cmax for Sitagliptin and Metformin	Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.	baseline through 72 hours postdose	No