Hongtao Li, Rongfang Shan, Jiaxiang Ding, Jialin Zhang, Bingyan Liu, Qin Ge, Dongmei Cheng, Lufeng Li, Chaoyang Zhang, He Su, Xiaoyue Li, Huiru Li, Jingjing Ye, Hui Li, Fengxian Li, Huan Zhou, Qiang Huo, Yue Su
OBJECTIVES: To compare the pharmacokinetic and safety of the test group capecitabine tablets (0.5 g) and the reference group capecitabine tablets (0.5 g). METHODS: This study was registered at www.chinadrugtrials.org.cn under the registration number CTR20220138. 48 subjects with solid tumor were recruited and randomized to receive either the test group or the reference group at a dose of 2 g per cycle for three cycles of the entire trial. RESULTS: The point estimate of the geometric mean ratio of Cmax for the subject and reference groups was 1...
December 7, 2023: Expert Opinion on Drug Metabolism & Toxicology