/ Not yet recruitingNot Applicable 瑞卢戈利片在健康男性受试者中随机、开放、两制剂、单次给药、四周期、完全重复交叉空腹和餐后状态下的生物等效性试验
[Translation] A randomized, open-label, two-dose, single-dose, four-period, fully repeated crossover bioequivalence study of relugolix tablets in healthy male subjects under fasting and fed conditions
主要目的:以广东方盛健盟药业有限公司持证,湖南方盛制药股份有限公司生产的瑞卢戈利片为受试制剂,以Accord Healthcare S.L.U持证的瑞卢戈利片(商品名:ORGOVYX®)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。
次要目的:评价中国健康男性受试者单次空腹/餐后口服瑞卢戈利片受试制剂和参比制剂后的安全性。
[Translation] Main purpose: To use the test preparation of relugolix tablets licensed by Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd. and produced by Hunan Fangsheng Pharmaceutical Co., Ltd., and the reference preparation of relugolix tablets (trade name: ORGOVYX®) licensed by Accord Healthcare S.L.U., to investigate the pharmacokinetic parameters and relative bioavailability of the two preparations in the fasting and postprandial state, and to evaluate whether the two preparations are bioequivalent.
Secondary purpose: To evaluate the safety of the test preparation and reference preparation of relugolix tablets after a single oral administration on an empty stomach/postprandial basis in healthy Chinese male subjects.
/ CompletedNot Applicable 比索洛尔氨氯地平片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of bisoprolol and amlodipine tablets in humans under fasting and fed conditions
考察空腹及餐后条件下,健康受试者单次口服由广东方盛健盟药业有限公司提供的比索洛尔氨氯地平片【受试制剂,规格:富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg】与相同条件下单次口服由Merck Kft持证的比索洛尔氨氯地平片【参比制剂,规格:富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg】的药动学特征,评价两制剂间的生物等效性及安全性,为受试制剂的注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single oral administration of bisoprolol amlodipine tablets [test preparation, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] provided by Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd. in healthy subjects under fasting and postprandial conditions and a single oral administration of bisoprolol amlodipine tablets [reference preparation, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] certified by Merck Kft under the same conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.
100 Clinical Results associated with Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd.
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100 Deals associated with Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd.