A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)

Phase 1

Completed

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

• Registration Number: NCT00961857
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-01
• Primary Completion: 2005-12-01
• Study Completion: 2006-01-01
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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
• Subject is willing to avoid strenuous physical activity during the study
• Subject agrees to refrain from eating grapefruit or grapefruit products during the study

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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 consumes excessive amounts of alcohol or caffeinated beverages
• Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
• Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food
• Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin
• Subject is a regular user or past abuser of any illicit drugs
• Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies during the study.
• Subject is a nursing mother

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	sitagliptin phosphate (+) metformin hydrochloride	Individual Tablets of 50 mg sitagliptin and 500 mg metformin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets	72 hours post dose