[Translation] Bioequivalence study of methotrexate tablets in humans under fasting and fed conditions
主要研究目的
研究健康受试者在空腹及餐后条件下,单次口服由海南卓科制药有限公司提供的甲氨蝶呤片(受试制剂,规格:2.5mg)与相同条件下单次口服由Pfizer Japan Inc.持证的甲氨蝶呤片(参比制剂,商品名:METHOTREXATE®,规格:2.5mg)的药动学特征,评价两制剂间的生物等效性,为该受试制剂注册申请提供依据。
次要研究目的
观察健康受试者在空腹及餐后条件下单次分别口服1片受试制剂或1片参比制剂的安全性。
[Translation] Main study objectives
To study the pharmacokinetic characteristics of a single oral administration of methotrexate tablets (test preparation, specification: 2.5 mg) provided by Hainan Zhuoke Pharmaceutical Co., Ltd. and a single oral administration of methotrexate tablets (reference preparation, trade name: METHOTREXATE®, specification: 2.5 mg) certified by Pfizer Japan Inc. under the same conditions in healthy subjects under fasting and postprandial conditions, to evaluate the bioequivalence between the two preparations and provide a basis for the registration application of the test preparation.
Secondary study objectives
To observe the safety of a single oral administration of one tablet of the test preparation or one tablet of the reference preparation in healthy subjects under fasting and postprandial conditions.
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