Table 2 Bioequivalence analysis of Metformin and vildagliptin after single oral administration of test and reference products.

From: Bioequivalence assessment between two formulations of a film-coated fixed-dose combination of metformin and vildagliptin (850/50mg) in healthy Tunisian subjects under fed conditions

Parameters

Geometric means

GMR%

90% CI

CV%

Test (N = 18)

Reference (N = 18)

Metformin

 Cmax(ng/ml)

1679.60

1725.66

97.33

92.01–102.66

14.11

 AUC0→24h (ng.hr/mL)

12596.34

12895.93

97.68

93.55–101.80

10.89

 AUC0→∞ (ng.hr/mL)

12815.62

13150.77

97.45

93.32–101.58

10.93

Vildagliptin

 Cmax(ng/ml)

234.58

230.98

101.56

96.03–107.09

14.05

 AUC0→24h (ng.hr/mL)

945.25

962.70

98.19

94.46–101.92

9.80

 AUC0→∞ (ng.hr/mL)

945.25

962.70

98.19

94.46–101.92

9.80

  1. CI: confidence interval, AUC0→24 h: area under the curve zero to 24 h, AUC0→∞: area under the curve zero to infinity, Cmax: maximum concentration, GMR: geometric mean T/R ratio, CV%: intra-subject coefficient of variation.
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