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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

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