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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

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

Criteria

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