[Translation] Research protocol for a single-center, randomized, open-label, two-preparation, single-dose, two-cycle, two-sequence, double-crossover fasting/postprandial bioequivalence trial of methotrexate tablets in healthy subjects
以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂甲氨蝶呤片(持证商:南京泽恒医药技术开发有限公司)与参比制剂甲氨蝶呤片(持证商:Pfizer Japan Inc.,商品名:METHOTREXATE)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
[Translation] Pharmacokinetic parameters were used as the primary endpoint evaluation index to compare the oral administration of the test preparation methotrexate tablets (license holder: Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.) and the reference preparation methotrexate tablets in the fasting/postprandial state. The pharmacokinetic behavior of pterin tablets (licensee: Pfizer Japan Inc., trade name: METHOTREXATE) in healthy subjects was evaluated to evaluate the bioequivalence of the two preparations.