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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: sitagliptin phosphate (+) metformin hydrochloride

• Registration Number: NCT00961480
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	sitagliptin phosphate (+) metformin hydrochloride	50 mg sitagliptin and 500 mg metformin as individual tablets

Primary Outcome Measures

Name	Time	Method
The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.	Up to 72 hours postdose

Secondary Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax) for metformin after administration of sitagliptin/metformin (50/500; 50/850, 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.	Up to 72 hours postdose