Bioequivalence study of dacomitinib and Vizimpro® in healthy Chinese volunteers under fasting and fed conditions: A randomized, open-label, single-dose, crossover trial.

ABSTRACT: This study aimed to evaluate the bioequivalence between test tablet dacomitinib and reference product Vizimpro® under fasting and fed conditions and assess their pharmacokinetic (PK) and safety profiles for gaining marketing approval of the new generic drug. A single-center, randomized, open-label, single-dose, two-treatment, two-period, crossover bioequivalence study was conducted in healthy Chinese subjects. Eligible healthy subjects randomly received a single 45 mg dose of test or reference formulations with an administration sequence of test tablet (T), reference tablet (R), or (RT), under both fasting and fed conditions, and each single administration was followed by a 21-day washout period. Plasma concentrations and corresponding non-compartmental PK parameters of dacomitinib were de

SUBMITTER: Yang X 

PROVIDER: S-EPMC10719465 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature