Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 61
Healthy volunteers: yes

Brief summary:
This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.

Detailed description:

Arms:
arm 1: Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2. arm 2: Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.

Interventions: intervention 1: Sitagliptin phosphate/metformin hydrochloride FDC intervention 2: Sitagliptin phosphate intervention 3: Metformin hydrochloride
Intervention descriptions: intervention 1: Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods. intervention 2: Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods. intervention 3: Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Protocol document: