Table 1: Results Obtained with the ANOVA Test from the Data without Ln-Transformation. The Bioequivalence Conclusion with the Data Ln Transformed is not Affected

Parameter Men Women M+W
AUC0-48 (ng*h/mL) AUCTest 1678 1173 1425
AUCRef 1766 1233 1499
AUCaverage 1722 1203 1462
T/R 0.95 0.95 0.95
CV (%) 27 62 43
CI 90% 0.76-1.14 0.52-1.39 0.74-1.16
CI 90% width 0.38 0.87 0.42
Cmax (ng/mL) CmaxTest 135.8 108.0 121.9
CmaxRef 154.0 109.0 131.5
Cmaxaverage 144.9 108.5 126.7
T/R 0.88 0.99 0.93
CV (%) 45 49 48
CI 90% 0.57-1.20 0.64-1.34 0.69-1.16
CI 90% width 0.63 0.70 0.47
Tmax (h) TmaxTest 4.8 4.3 4.5
TmaxRef 3.9 4.8 4.3
Tmaxaverage 4.3 4.5 4.4
Kel(h-1) KelTest 0.0383 0.0347 0.0304
KelRef 0.0390 0.0353 0.0316
Kelaverage 0.0387 0.0350 0.0310
T/R 0.98 0.99 0.96
CV (%) 16 42 32
CI 90% 0.84-1.09 0.64-1.28 0.81-1.12
CI 90% width 0.25 0.64 0.31

T/R, test-reference ratio; AUC, area under the plasma concentration time curve from 0 to 48 hours; Cmax, maximum plasma concentration; Kel, elimination constant; Tmax, time for Cmax; CV, ANOVA’s coefficient of variation; CI 90%, 90% confidence interval; CI 90% width, obtained by subtracting the CI 90% boundaries.