盐酸丙卡特罗干糖浆在中国健康人群中单次给药的人体生物等效性临床试验
[Translation] A human bioequivalence clinical trial of single-dose Procaterol hydrochloride dry syrup in healthy Chinese people
主要目的:以持证商为大塚製薬株式会社的盐酸丙卡特罗干糖浆(商品名:Meptin,规格:0.005%(g/g))为参比制剂,以重庆万霖生物医药科技有限公司研发的盐酸丙卡特罗干糖浆(规格:10g:0.5mg)为受试制剂,评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main purpose: Use Procaterol Hydrochloride Dry Syrup (trade name: Meptin, Specification: 0.005% (g/g)) from Otsuka Seiki Co., Ltd. as the reference preparation, and Chongqing Wanlin Biomedical Technology Co., Ltd. The developed procaterol hydrochloride dry syrup (specification: 10g: 0.5mg) was the test preparation to evaluate the bioequivalence of the two preparations in Chinese healthy subjects under fasting and postprandial conditions.
Secondary purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.
水溶性黄体酮注射液在中国健康绝经后女性中的一项随机、开放、单次给药、两制剂、两序列、两周期交叉的生物等效性研究。
[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-cycle crossover bioequivalence study of water-soluble progesterone injection in healthy Chinese postmenopausal women.
主要目的:观察单次皮下注射受试制剂水溶性黄体酮注射液[规格:1.112ml:25mg,药品上市许可持有人为重庆万霖生物医药科技有限公司]与参比制剂水溶性黄体酮注射液[商品名:Lubion,规格:1.112ml:25mg,持证商IBSA Farmaceutici Italia Srl]在中国健康绝经后女性体内的药代动力学特征,评估单次皮下注射水溶性黄体酮注射液两种制剂之间的生物等效性及个体内变异度。
次要目的:观察受试制剂和参比制剂,在中国健康绝经后女性中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of a single subcutaneous injection of the test preparation water-soluble progesterone injection [Specification: 1.112ml: 25mg, the drug marketing authorization holder is Chongqing Wanlin Biopharmaceutical Technology Co., Ltd.] and the reference preparation water-soluble progesterone injection [trade name: Lubion, specification: 1.112ml: 25mg, licensee IBSA Farmaceutici Italia Srl] in healthy postmenopausal women in China, and to evaluate the bioequivalence and intra-individual variability between the two preparations of a single subcutaneous injection of water-soluble progesterone injection.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy postmenopausal women in China.
100 Clinical Results associated with Chongqing Wanlin Biomedical Technology Co., Ltd.
0 Patents (Medical) associated with Chongqing Wanlin Biomedical Technology Co., Ltd.
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100 Translational Medicine associated with Chongqing Wanlin Biomedical Technology Co., Ltd.