[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of finasteride tablets in Chinese healthy subjects under fasting and fed conditions
主要目的:本研究以辰光(天津)制药有限公司的非那雄胺片(5mg)为受试制剂,Merck Sharp & Dohme Limited持证的非那雄胺片(商品名:保列治®,规格:5mg)为参比制剂,评价受试制剂和参比制剂在空腹和餐后条件下给药时的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: This study used finasteride tablets (5 mg) from Chenguang (Tianjin) Pharmaceutical Co., Ltd. as the test preparation and finasteride tablets (trade name: Proscar®, specification: 5 mg) from Merck Sharp & Dohme Limited as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation when administered under fasting and postprandial conditions.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.