Bioequivalence of capecitabine tablets in cancer patients / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
;
(12): 1119-1124, 2020.
Artigo
em Chinês
| WPRIM
| ID: wpr-855761
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.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Tipo de estudo:
Ensaio Clínico Controlado
Idioma:
Chinês
Revista:
Chinese Journal of Clinical Pharmacology and Therapeutics
Ano de publicação:
2020
Tipo de documento:
Artigo
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