Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 96
Healthy volunteers: yes

Brief summary:
The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.

Detailed description:

Arms:
arm 1: 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/850 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 850 mg metformin tablets single dose in randomized order arm 2: 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/850 mg metformin and single Empagliflozin(5mg) and metformin (850mg) tablets single dose in randomized order arm 3: 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/500 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 500 mg metformin tablets single dose in randomized order arm 4: 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/500 mg metformin and single Empagliflozin(5mg) and metformin (500mg) tablets single dose in randomized order

Interventions: intervention 1: 5 mg empagliflozin/850 mg metformin FDC intervention 2: 12.5 mg empagliflozin intervention 3: 12.5 mg empagliflozin intervention 4: 850 mg metformin intervention 5: 5 mg empagliflozin intervention 6: 5 mg empagliflozin intervention 7: 850 mg metformin intervention 8: 12.5 mg empagliflozin/850 mg metformin FDC intervention 9: 12.5 mg empagliflozin/500 mg metformin FDC intervention 10: 5 mg empagliflozin/500 mg metformin FDC intervention 11: 500 mg metformin intervention 12: 500 mg metformin
Intervention descriptions: intervention 1: 5 mg empagliflozin/850 mg metformin FDC intervention 2: 10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet intervention 3: 10mg empagliflozin tablet and 2.5 mg empagliflozin tablet intervention 4: 850mg metformin tablet intervention 5: 5 mg empagliflozin intervention 6: 5 mg empagliflozin intervention 7: 850 mg metformin intervention 8: 12.5 mg empagliflozin/850 mg metformin FDC intervention 9: 12.5 mg empagliflozin/500 mg metformin FDC intervention 10: 5 mg empagliflozin/500 mg metformin FDC intervention 11: 500 mg metformin intervention 12: 500 mg metformin

Protocol document: