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

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 Cmax , AUC0-t and AUC0-∞ of CAP T/R reagent were 90.26%, 95.27%, and 95.07, respectively. The values and 90% confidence intervals (CI) of AUC0-t , AUC0-∞ , and Cmax 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.