[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence, two-crossover bioequivalence study of megestrol acetate dispersible tablets in male health study participants under fasting and fed conditions
主要目的:以南京臣功制药股份有限公司研发的醋酸甲地孕酮分散片(规格:160mg)为受试制剂,PharmaSwiss ?eská republika s.r.o.持证的醋酸甲地孕酮片(商品名:Megace®,规格:160mg)为参比制剂,在空腹和餐后状态下考察两制剂在男性健康研究参与者中的生物等效性。
次要目的:观察受试制剂醋酸甲地孕酮分散片和参比制剂醋酸甲地孕酮片(Megace®)在男性健康研究参与者中的安全性。
[Translation] Primary Objective: To investigate the bioequivalence of the test formulation (160 mg megestrol acetate dispersible tablets) developed by Nanjing Chengong Pharmaceutical Co., Ltd. and the reference formulation (160 mg megestrol acetate tablets, licensed by PharmaSwiss?eská republika s.r.o., trade name: Megace®) in male healthy study participants under fasting and fed conditions.
Secondary Objective: To investigate the safety of the test formulation (160 mg megestrol acetate dispersible tablets) and the reference formulation (160 mg megestrol acetate tablets, licensed by PharmaSwiss?eská republika s.r.o.) in male healthy study participants.