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 LLC24 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

sitagliptin phosphate (+) metformin hydrochloride

place holder - do not post

Comparator: metformin 500mgDRUG

A single dose of metformin 500 mg tablet

Comparator: sitagliptinDRUG

A single dose of 50 mg sitagliptin tablet

Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tabletDRUG

A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet

Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tabletDRUG

A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tabletDRUG

A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

Comparator: metformin 1000 mgDRUG

A single dose of metformin 1000 mg tablet

Comparator: metformin 850 mgDRUG

A single dose of metformin 850 mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 72 hours postdose

Secondary Outcomes

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.

Time frame: Up to 72 hours postdose

Data from ClinicalTrials.gov

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