Dataset from A Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir in Healthy Adult Volunteers Under Fasting Conditions

In a phase 1, open-label, crossover study to evaluate the relative bioavailability of a tablet formulation of ravidasvir (test) versus the capsule formulation of ravidasvir (reference) in 24 healthy adult volunteers (PPI-668-104 study), relatively high intra-subject coefficients of variation were observed for both Cmax and AUC0-t.A two-sequence, four-period replicate design will be used to allow the possibility to scale the acceptance range for Cmax if the observed intra-subject coefficient of variation for the reference formulation is greater than 30%

在一项纳入24名健康成年志愿者的I期开放标签交叉试验（PPI-668-104研究）中，旨在评估拉维达韦（ravidasvir）片剂制剂（试验制剂）相较于其胶囊剂（参比制剂）的相对生物利用度。试验期间观察到，受试制剂与参比制剂的峰浓度（Cmax）及零时至末次取样时间的血药浓度-时间曲线下面积（AUC0-t）均存在较高的受试者内变异系数。本研究将采用两序列四周期重复设计，若参比制剂的受试者内变异系数观测值超过30%，则可对Cmax的接受范围进行调整。