Bioequivalence
Except for one subject who withdrew after the first cycle, a total of 71
subjects entered the BE assessment. The geometric mean ratios (GMRs)
(90%CI) of Cmax, AUC0-t and
AUC0-∞ were 97.84%, 99.60% and 99.12% under fasting
condition, and the GMRs (90%CI) of Cmax,
AUC0-t and AUC0-∞ were 102.89%,
103.41% and 103.25% under postprandial condition. All these 90% CIs
were within the range of BE from FDA guidelines (80% to 125%). The
results are shown in Table 4 and Table 5. A sensitivity analysis in
Table 6 was performed to evaluate the influence of the dropout including
data from the withdraw subject who completed the first cycle only. The
GMRs (90%CI) of Cmax, AUC0-t and
AUC0-∞ were 102.86% 103.39% and 103.22%. These 90%
CIs from sensitivity analysis were within the same range of BE.