Bioequivalence trial of fasting oral sorafenib tosylate tablets in healthy Chinese subjects / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
; (12): 281-286, 2022.
Article
de Zh
| WPRIM
| ID: wpr-1014877
Bibliothèque responsable:
WPRO
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
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Indice:
WPRIM
langue:
Zh
Texte intégral:
Chinese Journal of Clinical Pharmacology and Therapeutics
Année:
2022
Type:
Article