Pharmacokinetics and bioequivalence of S-I capsules in Chinese patients with cancer

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	Pharmacokinetics and bioequivalence of S-I capsules in Chinese patients with cancer
	Zou Huiyu 1; Chen Xiaoyan2 ; Zhang Yifan2 ; Liu Ke 2; Zhong Dafang1
刊名	The Chinese Journal of Clinical Pharmacology
	2010
卷号	26 期号:5 页码:349-354
关键词	S-I LC-MS/MS pharmacokinetics bioequivalence
ISSN号	1001-6821
其他题名	替吉奥胶囊(S-I)在中国癌症患者体内的药代动力学和生物等效性
文献子类	Article
英文摘要	Objective To study the pharmacokinetics and bioequivalence of S-I in Chinese patients with cancer after single oral administration. Methods A single dose of 50 mg test and reference formulations were given according to an open randomized two way crossover design. The plasma concentrations of tegafur(FT),5-fluorouracil (5-FU), gimeracil (CDHP), and oxonic acid(Oxo) in plasma were determined by liquid chromatography-tandem mass spectrometry. Results The main pharmacokinetic parameters of test and reference formulations were as follows:the values of C_(max)for FT were (1887.0491.0) and (1876.0 522.0)ng.mL~(-1),t_(1/2)were (11.55.3)and (11.65.0)h,AUC_(O-t) were (20.89.6)and (19.8l0.0)ug.h.mL~(-1), respectively. The values of C_(max)for 5-FU were (121.844.3) and (119.745.1) ng ' mL~(-1),t_(1/2)were (2.21.8)and (2.11.6)h,AUC_(O-t)were (591.2 176.2) and (580.1186.9) ng h.mL~(-1), respectively. The values of C_(max)for CDHP were(304.6107.3)and(297.2103.6)ng.mL ~(-1),t_(1/2)were(4.11.8)and(4.02.5)h,AUC_ (O-t)were (1458.O1094.0)and (1410.01043.0)ng.h.mL~(-1)respectively. The valuesof C_ (max)for Oxo were (77.477.3)and(79.973.4)ng.mL ~(-1),t_(1/2)were(4.72.7)and(4.32.0)h,AUC_(0-t)were(403.7333.2)and(427.8377.3)ng.h.mL ~(-1), respectively. The relative bioavailability of FT.5-FU,CDHP and Oxo in test for-mulation were (108.123.6)%,(104.924.2)%,(107.223.9)% and (103.439.0)%, respectively. Conclusion The result demonstrated that two formulations were bioequivalent by analysis of variance, two on-sided t test and 90% confidence interval
WOS研究方向	Pharmacology & Pharmacy (provided by Clarivate Analytics)
语种	中文
CSCD记录号	CSCD:3960251
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/267918]
专题	上海药物代谢研究中心
通讯作者	Zhong Dafang
作者单位	1.Soochow University, Suzhou, Jiangsu 215000, China.; 2.Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.
推荐引用方式 GB/T 7714	Zou Huiyu,Chen Xiaoyan,Zhang Yifan,et al. Pharmacokinetics and bioequivalence of S-I capsules in Chinese patients with cancer[J]. The Chinese Journal of Clinical Pharmacology,2010,26(5):349-354.
APA	Zou Huiyu,Chen Xiaoyan,Zhang Yifan,Liu Ke,&Zhong Dafang.(2010).Pharmacokinetics and bioequivalence of S-I capsules in Chinese patients with cancer.The Chinese Journal of Clinical Pharmacology,26(5),349-354.
MLA	Zou Huiyu,et al."Pharmacokinetics and bioequivalence of S-I capsules in Chinese patients with cancer".The Chinese Journal of Clinical Pharmacology 26.5(2010):349-354.