[Translation] A randomized, open-label, two-dose, two-period controlled study to evaluate the bioequivalence of a single oral dose of 50 mg azathioprine tablets in healthy subjects under fasting conditions
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] The time course of blood drug concentration after a single oral dose of the test preparation azathioprine tablets (50 mg, manufacturer: Zhejiang Aotokang Pharmaceutical Group Co., Ltd.) was observed in healthy subjects in the fasting state, and the corresponding pharmacokinetic parameters were estimated. The human relative bioavailability and bioequivalence studies were conducted using azathioprine tablets (50 mg, Aspen Pharmacare Australia Pty Ltd, trade name: IMURAN®) as the reference preparation to provide a reference for the consistency evaluation and clinical application of the drug.