{"title":"两种卡培他滨片剂在中国实体瘤癌症患者中的药代动力学和生物等效性研究","authors":"Guangnan Zong, Jinlin Li, Xiushan Gong, Yuanyuan Liu, Xiuli Guo","doi":"10.1007/s00280-024-04652-w","DOIUrl":null,"url":null,"abstract":"<p><p>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<sub>max</sub>, AUC<sub>0-t</sub> and AUC<sub>0-∞</sub> of CAP T/R reagent were 90.26%, 95.27%, and 95.07, respectively. The values and 90% confidence intervals (CI) of AUC<sub>0-t</sub>, AUC<sub>0-∞</sub>, and C<sub>max</sub> 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.</p>","PeriodicalId":9556,"journal":{"name":"Cancer Chemotherapy and Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.7000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Pharmacokinetic and bioequivalence study of two capecitabine tablets in Chinese patients with solid tumor cancer.\",\"authors\":\"Guangnan Zong, Jinlin Li, Xiushan Gong, Yuanyuan Liu, Xiuli Guo\",\"doi\":\"10.1007/s00280-024-04652-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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<sub>max</sub>, AUC<sub>0-t</sub> and AUC<sub>0-∞</sub> of CAP T/R reagent were 90.26%, 95.27%, and 95.07, respectively. The values and 90% confidence intervals (CI) of AUC<sub>0-t</sub>, AUC<sub>0-∞</sub>, and C<sub>max</sub> 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.</p>\",\"PeriodicalId\":9556,\"journal\":{\"name\":\"Cancer Chemotherapy and Pharmacology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Chemotherapy and Pharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00280-024-04652-w\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/3/7 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Chemotherapy and Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00280-024-04652-w","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/3/7 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
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.
期刊介绍：
Addressing a wide range of pharmacologic and oncologic concerns on both experimental and clinical levels, Cancer Chemotherapy and Pharmacology is an eminent journal in the field. The primary focus in this rapid publication medium is on new anticancer agents, their experimental screening, preclinical toxicology and pharmacology, single and combined drug administration modalities, and clinical phase I, II and III trials. It is essential reading for pharmacologists and oncologists giving results recorded in the following areas: clinical toxicology, pharmacokinetics, pharmacodynamics, drug interactions, and indications for chemotherapy in cancer treatment strategy.
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