Choriocarcinoma

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.

Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behaviors of the test preparation methotrexate tablets (licensed by: Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.) and the reference preparation methotrexate tablets (licensed by: Pfizer Japan Inc., trade name: METHOTREXATE) in healthy subjects after oral administration in the fasting/postprandial state were compared to evaluate the bioequivalence of the two preparations.

This study aims to study the pharmacokinetic characteristics of mercaptopurine microtablets (5 mg) developed and produced by China Resources Double Crane Pharmaceutical Co., Ltd. after a single oral administration after a meal; using Quinn Pharmaceuticals' certified mercaptopurine tablets (50 mg) as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the differences in human pharmacokinetic performance of the two preparations. Exploratory analysis: Evaluate the human bioequivalence of the two preparations.