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Pharmacokinetic and bioequivalence study of two capecitabine tablets in Chinese patients with breast, colorectal or gastric cancer under fed condition: A multicentric, randomized, open-label, single-dose, two-period, two-way crossover clinical trial by Haiping Ma; Naping Zhao; Suxia Luo; Yanqiao Zhang; Zhijun Yuan; Hao Sun; Shen Gao; Xianbao Zhan; Li Zhang is a Pharmacology, Toxicology and Pharmaceutics article available to read on EtoBox.

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Objective The aim of this study was to examine the pharmacokinetics, bioequivalence, and safety of two tablet formulations of capecitabine 500 mg in Chinese patients with breast, colorectal or gastric cancer under fed condition. Methods A multicentric, randomized, open-label, single-dose, two-period, two-way crossover trial was conducted by randomizing a single oral dose of test (T) or reference (R, Xeloda®) capecitabine (500 mg) to patients of either sex with colon, colorectal or breast cancer under fed condition (high-fat and high-calorie diet). Pharmacokinetic parameters were calculated using non-compartmental methods. Patients were monitored for safety and tolerability throughout the study. Results 74 subjects were randomly enrolled. The T/R geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for C max, AUC0-t and AUC0-∞ of capecitabine were 96.60% (85.87–108.67%), 99.07% (95.40–102.89%), 99.17% (95.29–103.21%), respectively. All 90% CIs fell within the bioequivalence acceptance range of 80.00–125.00%. The common adverse events (AEs) included clinically significant laboratory abnormalities and gastrointestinal diseases. There were no serious adverse events (SAEs) or

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Author

Haiping Ma; Naping Zhao; Suxia Luo; Yanqiao Zhang; Zhijun Yuan; Hao Sun; Shen Gao; Xianbao Zhan; Li Zhang

Publisher

Elsevier BV

Published

2023

Language

EN

Field

Pharmacology, Toxicology and Pharmaceutics (Life Sciences)