Pharmacokinetics and bioequivalence of sunitinib and Sutent^® in Chinese healthy subjects: an open-label, randomized, crossover study.

ABSTRACT: Purpose: The purpose of this study was to examine the pharmacokinetics (PK), bioequivalence and safety of generic sunitinib and its original product Sutent^® in healthy Chinese subjects through a phase-I clinical trial. Methods: The study selected two groups of 24 healthy Chinese subjects in a 1:1 ratio through random allocation. Each participant received either 12.5 mg of sunitinib or Sutent^® per cycle. A total of 15 different time points were employed for blood sample collection during each cycle. Furthermore, a comprehensive assessment of the drugs' safety was consistently maintained throughout the trial. Results: The average adjusted geometric mean ratios (GMR) (90% CI) for the primary PK parameters C_max, AUC_0-t and AUC

SUBMITTER: Wang Y 

PROVIDER: S-EPMC10667676 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature