Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: sitagliptin/metformin 50 mg/500 mg tablet; Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin; Drug: sitagliptin/metformin 50 mg/850 mg tablet; Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093794

0431A-122

2010_518

Details and patient eligibility

About

This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is of Chinese descent
• Subject is in good health
• Subject is a non-smoker

Exclusion criteria

• Subject has a history of stroke or chronic seizures
• Subject has a history of cancer
• Subject has had major surgery, donated blood or participated in another investigational 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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28 participants in 4 patient groups

1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850

Experimental group

Description:

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 500 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg sitagliptin and 850 mg metformin

Treatment:

Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin

Drug: sitagliptin/metformin 50 mg/850 mg tablet

Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin

Drug: sitagliptin/metformin 50 mg/500 mg tablet

2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC

Experimental group

Description:

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * sitagliptin/metformin 50 mg/500 mg FDC tablet * Co-administration of 50 mg sitagliptin and 850 mg metformin * Co-administration of 50 mg sitagliptin and 500mg metformin * sitagliptin/metformin 50 mg/850 mg FDC tablet

Treatment:

Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin

Drug: sitagliptin/metformin 50 mg/850 mg tablet

Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin

Drug: sitagliptin/metformin 50 mg/500 mg tablet

3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500

Experimental group

Description:

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 850 mg metformin * sitagliptin/metformin 50 mg/850 mg FDC tablet * sitagliptin/metformin 50 mg/500 mg FDC tablet * Co-administration of 50 mg sitagliptin and 500mg metformin

Treatment:

Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin

Drug: sitagliptin/metformin 50 mg/850 mg tablet

Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin

Drug: sitagliptin/metformin 50 mg/500 mg tablet

4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

Experimental group

Description:

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg sitagliptin and 500 mg metformin * Co-administration of 50 mg sitagliptin and 850 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet

Treatment:

Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin

Drug: sitagliptin/metformin 50 mg/850 mg tablet

Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin

Drug: sitagliptin/metformin 50 mg/500 mg tablet