/ CompletedNot Applicable 富马酸比索洛尔片在空腹和餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of bisoprolol fumarate tablets in humans under fasting and fed conditions
考察健康受试者在空腹及餐后条件下单次服用由武汉武药科技有限公司提供的富马酸比索洛尔片(受试制剂T,规格:5mg)与相同条件下单次服用由Merck Serono GmbH持证的富马酸比索洛尔片(参比制剂R,商品名:Concor®,规格:5mg)的药动学特征,评价两制剂的生物等效性及安全性,为受试制剂注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single dose of bisoprolol fumarate tablets (test preparation T, specification: 5 mg) provided by Wuhan Wuyao Technology Co., Ltd. in healthy subjects under fasting and postprandial conditions and a single dose of bisoprolol fumarate tablets (reference preparation R, trade name: Concor®, specification: 5 mg) certified by Merck Serono GmbH under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.
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