Pharmacokinetic and bioequivalence study of two capecitabine tablets in Chinese patients with solid tumor cancer.

Autor: Zong G; Department of Pharmacology, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, No. 44 Wen Hua Xi Road, Jinan, 250012, People's Republic of China.; Shandong New Times Pharmaceutical Co., Ltd, Linyi, People's Republic of China., Li J; Shandong New Times Pharmaceutical Co., Ltd, Linyi, People's Republic of China., Gong X; Shandong New Times Pharmaceutical Co., Ltd, Linyi, People's Republic of China., Liu Y; Clinical Trial Research Center, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People's Republic of China., Guo X; Department of Pharmacology, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, No. 44 Wen Hua Xi Road, Jinan, 250012, People's Republic of China. guoxl@sdu.edu.cn.
Jazyk: angličtina
Zdroj: Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2024 Oct; Vol. 94 (4), pp. 641-645. Date of Electronic Publication: 2024 Mar 07.
DOI: 10.1007/s00280-024-04652-w
Abstrakt: Capecitabine (CAP) is one of the fluoropyrimidine deoxynucleoside carbamates, which can be converted to 5-fluorouracil (5-FU) by thymine deoxynucleoside phosphorylase (dThdPase) to exert antitumor effects. The purpose of this study is to compare the pharmacokinetics (PK), bioequivalence (BE), and safety of two CAP tablets in Chinese patients with solid tumor cancer. The results showed that the geometric mean ratios (GMRs) of C max , AUC 0-t and AUC 0-∞ of CAP T/R reagent were 90.26%, 95.27%, and 95.07, respectively. The values and 90% confidence intervals (CI) of AUC 0-t , AUC 0-∞ , and C max all fall within the range of 80.00-125.00%. In addition, a total of 22 subjects in this study had 30 adverse events, with an incidence of 45.83%, and there were no serious adverse events and adverse events that led to withdrawal from the trial.
(© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Databáze: MEDLINE
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