Clinical trial NCT01093794
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-04-01; Completion date: 2010-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:

Arms: arm 1: 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 arm 2: 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 arm 3: 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 arm 4: 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
Interventions: intervention 1: Co-administration of 50 mg sitagliptin and 500 mg metformin intervention 2: sitagliptin/metformin 50 mg/500 mg tablet intervention 3: Co-administration of 50 mg sitagliptin and 850 mg metformin intervention 4: sitagliptin/metformin 50 mg/850 mg tablet
Intervention descriptions: intervention 1: Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours. intervention 2: Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours. intervention 3: Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours. intervention 4: Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

Protocol documents: