Table 5 Pharmacokinetic parameters of itraconazole in plasma and 90Â % confidence interval of difference in the average values of logarithmic parameters
Parameters | Number | Reference product (Batch A) | Test product (Batch B) | Difference in the averate values after logarithmic conversion | 90Â % Confidence interval of difference in the average values of logarithmic parameters |
|---|---|---|---|---|---|
Cmax (ng/mL) | 28 | 41.5 (23.6) | 64.2 (23.4) | log(1.764) | log(1.415) ~ log(2.198) |
AUC48 (ng h/mL) | 28 | 318 (166) | 453 (161) | log(1.592) | log(1.317) ~ log(1.926) |