/ CompletedNot Applicable 盐酸普萘洛尔滴剂(20 mg/mL)人体生物等效性研究
[Translation] Bioequivalence study of propranolol hydrochloride drops (20 mg/mL) in humans
以海南诺恩生物科技有限公司提供的盐酸普萘洛尔滴剂(规格:20 mg/mL)为受试制剂,以持证商为PIERRE FABRE DERMATOLOGIE的盐酸普萘洛尔口服溶液(规格:4.28mg/mL(相当于3.75mg普萘洛尔),商品名:HEMANGEOL)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性;同时评价两种制剂在健康人体中的安全性,并对受试者服用盐酸普萘洛尔滴剂和盐酸普萘洛尔口服溶液的适口性进行评价和比较。
[Translation] Propranolol hydrochloride drops (specification: 20 mg/mL) provided by Hainan Noen Biotechnology Co., Ltd. were used as the test preparation, and propranolol hydrochloride oral solution (specification: 4.28 mg/mL (equivalent to 3.75 mg propranolol), trade name: HEMANGEOL) from PIERRE FABRE DERMATOLOGIE was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety of the two preparations in healthy humans was evaluated, and the palatability of the subjects taking propranolol hydrochloride drops and propranolol hydrochloride oral solution was evaluated and compared.
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