[Translation] A randomized, open-label, two-preparation, two-cycle controlled design to evaluate the bioequivalence of a single oral dose of 50 mg of azathioprine tablets in healthy subjects in the fasting state
观察健康受试者空腹状态下单剂量口服受试制剂硫唑嘌呤片(50mg,生产企业:浙江奥托康制药集团股份有限公司)后血药浓度的经时过程,估算相应的药代动力学参数;并以硫唑嘌呤片(50mg,Aspen Pharmacare Australia Pty Ltd公司,商品名:IMURAN®)为参比制剂,进行人体相对生物利用度和生物等效性试验,为该药一致性评价和临床应用提供参考依据。
[Translation] To observe the time course of blood drug concentration after oral administration of a single dose of the test preparation azathioprine tablets (50mg, manufacturer: Zhejiang Otuokang Pharmaceutical Group Co., Ltd.) in healthy subjects in fasting state, and to estimate the corresponding pharmacokinetics parameters; and using azathioprine tablets (50mg, Aspen Pharmacare Australia Pty Ltd, trade name: IMURAN®) as the reference preparation, the relative bioavailability and bioequivalence tests in humans were carried out to evaluate the consistency of the drug and clinical trials. The application provides a reference basis.