Test (n=28) Reference (n=28) Pharmacokinetic endpoint (unit) Adjusted gMean ratio (Test/Reference [%]) Two-sided 90% confidence interval Intra-individual gCV (%)
Lower limit (%) Upper limit (%)
Glucophage Merck 1000 mg Glucophage BMS 1000 mg AUC0-inf (nmol•h/L) 97.2 91.5 103.3 13.3
Cmax (nmol/L) 98.4 90.8 106.6 17.7
Glucophage Merck 500 mg Glucophage BMS 500 mg AUC0-inf (nmol•h/L) 102.2 95.7 109.1 14.3
Cmax (nmol/L) 101.6 91.6 112.8 22.9
*Pharmacokinetic parameters were log transformed prior to fitting the analysis of variance model.
One subject vomited shortly after receiving study drug during the 500 mg phase, and the respective values of the pharmacokinetic endpoints were not included in the analyses
Table 3: Adjusted-by-treatment geometric means and relative bioavailability of metformin.*
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