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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
5 mg empagliflozin/850 mg metformin FDC
10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet
10mg empagliflozin tablet and 2.5 mg empagliflozin tablet
1276.23.86002 Boehringer Ingelheim Investigational Site
Beijing, China
AUC(0-∞) for Empagliflozin
Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC(0-∞) for Metformin
Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax for Empagliflozin
Maximum measured concentration of the empagliflozin in plasma
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax for Metformin
Maximum measured concentration of the metformin in plasma
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC(0-tz) of Empagliflozin
Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 up to the last quantifiable data point
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC(0-tz) of Metformin
Area under the concentration-time curve of the metformin in plasma over the time interval from 0 up to the last quantifiable data point
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850mg metformin tablet
5 mg empagliflozin
5 mg empagliflozin
850 mg metformin
12.5 mg empagliflozin/850 mg metformin FDC
12.5 mg empagliflozin/500 mg metformin FDC
5 mg empagliflozin/500 mg metformin FDC
500 mg metformin
500 mg metformin
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration