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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Comparator: FMI sitagliptin/metformin 50 mg/500 mg FDC tablet; Drug: Comparator: metformin 500 mg; Drug: sitagliptin phosphate (+) metformin hydrochloride; Drug: Comparator: metformin 1000 mg; Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet; Drug: Comparator: sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00961857

MK0431A-048

0431A-048

2009_635

Details and patient eligibility

About

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).

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Treatment A

Active Comparator group

Description:

Individual Tablets of 50 mg sitagliptin and 500 mg metformin

Treatment:

Drug: Comparator: metformin 500 mg

Drug: sitagliptin phosphate (+) metformin hydrochloride

Drug: Comparator: sitagliptin

Treatment B

Experimental group

Description:

Sitagliptin/metformin 50 mg/500 mg tablet

Treatment:

Drug: Comparator: FMI sitagliptin/metformin 50 mg/500 mg FDC tablet

Treatment C

Active Comparator group

Description:

Individual Tablets of 50 mg sitagliptin and 1000 mg metformin

Treatment:

Drug: Comparator: metformin 1000 mg

Drug: Comparator: sitagliptin

Treatment D

Experimental group

Description:

sitagliptin/metformin 50 mg/1000 mg tablet

Treatment:

Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet