Bioequivalence of capecitabine tablets in cancer patients
10.12092/j.issn.1009-2501.2020.10.006
- VernacularTitle: 卡培他滨片在肿瘤患者中的生物等效性研究
- Author:
Guofang XU
1
Author Information
1. People's Hospital of Zhengzhou
- Publication Type:Journal Article
- Keywords:
5-FU;
Bioequivalence;
Capecitabine;
Pharmacokinetic
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(10):1119-1124
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To evaluate the pharmacokinetics, bioequivalence, and safety of capecitabine tablet in cancer patients following single oral administration. METHODS: Based on an open-randomized two-period crossover designation, subjects were orally given capecitabine tablet (test or reference products, 0.6 g single dosage). Blood samples were then collected and the plasma concentrations of capecitabine and its active metabolite, 5-fluorouracil (5-FU) were examined by HPLC-MS/MS. The bioequivalence between the test and reference formulations were evaluated with the pharmacokinetic parameters determined by the Phoenix WinNonlin 7.0 software. RESULTS: The numbers of the major pharmacokinetic parameters in patients treated with test and reference products were similar. To analyze the numbers of Cmax, tmax, AUC0-t, AUC0-∞, the 90% confidence interval (CI) for Cmax, AUC0-t and AUC0-∞ were 84.48-106.70, 93.03-96.54 and 96.34-102.84, respectively. For the 5-FU, the 90%CI of the for Cmax, AUC0-t and AUC0-∞ were 84.32-99.67, 90.55-98.76 and 96.99-103.48, respectively. Both sets of numbers fell within the bioequivalent limit ranges of 80.00%-125.00%. No serious adverse event was observed. CONCLUSION: The current data indicate that the test and reference formulations of capecitabine tablets were bioequivalent in cancer patients.
