Bioequivalence trial of fasting oral sorafenib tosylate tablets in healthy Chinese subjects

Author: Juan WU ¹ ; Zhiqiang WANG ¹ ; Renpeng ZHOU ¹ ; Jingjing YANG ¹ ; Huiling QIN ¹ ; Qian ZHANG ¹ ; Chao LU ¹ ; Wei HU ¹ ; Juan WU ² ; Zhiqiang WANG ² ; Renpeng ZHOU ² ; Jingjing YANG ² ; Huiling QIN ² ; Qian ZHANG ² ; Chao LU ² ; Wei HU ²
Author Information

1. Department of Clinical Pharmacology, The Second Hospital of Anhui Medical University
2. Anhui Provincial Institute of Translational Medicine
Publication Type:Journal Article
Keywords: Bioequivalence; Pharmacokinetics; Sorafenib
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(3):281-286
CountryChina
Language:Chinese
Abstract: AIM: To compare the pharmacokinetic behavior of a single oral sorafenib tosylate tablets in Chinese healthy subjects under fasting conditions and evaluate the bioequivalence of the test reagent (T) and the reference reagent (R). METHODS: A single-center, randomized, open-labeled, two-agent, three-period, three-sequence (TRR, RTR, RRT), and partially repeated crossover trial design was adopted. The trial was administered once per cycle (0.2 g) under fasting conditions. 36 healthy subjects were randomly divided into 3 groups, each with 12 cases. RESULTS: Thirty-six healthy subjects (9 females, average age 31 years) were enrolled in the trial. The upper limits of the one-sided 95% confidence interval of the pharmacokinetic parameters C