[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation methotrexate tablets (strength: 2.5 mg) and the reference formulation METHOTREXATE® (strength: 2.5 mg) in healthy adult subjects in the fasting and fed state
主要研究目的:研究空腹和餐后状态下单次口服受试制剂甲氨蝶呤片(规格:2.5 mg,通化茂祥制药有限公司生产)与参比制剂甲氨蝶呤片(METHOTREXATE®,规格:2.5 mg,ファイザー株式会社生产)在健康受试者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:研究受试制剂甲氨蝶呤片(规格:2.5 mg)和参比制剂METHOTREXATE®(规格:2.5 mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation methotrexate tablets (specification: 2.5 mg, produced by Tonghua Maoxiang Pharmaceutical Co., Ltd.) and the reference preparation methotrexate tablets (METHOTREXATE®, specification: 2.5 mg, produced by ファイザー Co., Ltd.) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary purpose of the study: to study the safety of the test preparation methotrexate tablets (specification: 2.5 mg) and the reference preparation METHOTREXATE® (specification: 2.5 mg) in healthy subjects.