[Translation] Bioequivalence study of testosterone undecanoate soft capsules in healthy postmenopausal female subjects in a single center, randomized, open, single administration, two preparations, four cycles, fully repeated crossover postprandial state
以浙江医药股份有限公司新昌制药厂生产的十一酸睾酮软胶囊(规格:40mg)为受试制剂,以持证商为N.V.Organon,生产厂家为Catalent France Beinheim S.A.的十一酸睾酮软胶囊(商品名:安特尔®,规格:40mg)为参比制剂,按生物等效性试验的相关规定,比较十一酸睾酮软胶囊在中国健康绝经后女性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。同时,评价健康绝经后女性受试者单次餐后口服十一酸睾酮软胶囊受试制剂和参比制剂后的安全性。
[Translation] Testosterone undecanoate soft capsules (specification: 40 mg) produced by Zhejiang Pharmaceutical Co., Ltd. Xinchang Pharmaceutical Factory were used as the test preparation, and testosterone undecanoate soft capsules were produced by Catalent France Beinheim S.A. ( Trade name: Antal®, specification: 40mg) is the reference preparation, and the pharmacokinetic behavior of testosterone undecanoate soft capsules in Chinese healthy postmenopausal female subjects was compared according to the relevant regulations of bioequivalence test , to evaluate the bioequivalence of the two preparations. At the same time, the safety of the test preparation and the reference preparation of testosterone undecanoate soft capsules were orally administered to healthy postmenopausal female subjects after a single meal.