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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: sitagliptin phosphate (+) metformin hydrochloride; Drug: Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet; Drug: Comparator: metformin 500mg; Drug: Comparator: metformin 850 mg; Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet; Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet; Drug: Comparator: sitagliptin; Drug: Comparator: metformin 1000 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00961480

0431A-095

MK0431A-095

2009_636

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Treatment A

Active Comparator group

Description:

50 mg sitagliptin and 500 mg metformin as individual tablets

Treatment:

Drug: Comparator: sitagliptin

Drug: sitagliptin phosphate (+) metformin hydrochloride

Drug: Comparator: metformin 500mg

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:

50 mg sitagliptin and 1000 mg metformin as individual tablets

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

Treatment E

Active Comparator group

Description:

50 mg sitagliptin and 850 mg metformin as individual tablets

Treatment:

Drug: Comparator: sitagliptin

Drug: Comparator: metformin 850 mg

Treatment F

Experimental group

Description:

sitagliptin/metformin 50 mg/850 mg tablet

Treatment:

Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet