/ Not yet recruitingNot Applicable 琥珀酰明胶电解质醋酸钠注射液在中国健康受试者中随机、开放、两制剂、单次给药、两周期、双交叉的生物等效性试验
[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of succinylated gelatin electrolyte sodium acetate injection in Chinese healthy subjects
主要研究目的：比较健康成年人群，单次静脉输注北京布霖生物科技有限公司的琥珀酰明胶电解质醋酸钠注射液(规格：500ml：20g)与贝朗医疗(苏州)有限公司生产的琥珀酰明胶电解质醋酸钠注射液(商品名：佳乐攀®，规格：500ml：20g)后，两种制剂人体药代动力学特点，评价两种制剂间的生物等效性。次要研究目的：评价两种制剂的安全性。
[Translation] The main purpose of the study is to compare the pharmacokinetic characteristics of the two preparations in healthy adults after a single intravenous infusion of succinylated gelatin electrolyte sodium acetate injection (specification: 500ml: 20g) produced by Beijing Bulin Biotechnology Co., Ltd. and succinylated gelatin electrolyte sodium acetate injection (trade name: Jialepan®, specification: 500ml: 20g) produced by B. Braun Medical (Suzhou) Co., Ltd., and to evaluate the bioequivalence between the two preparations. The secondary purpose of the study is to evaluate the safety of the two preparations.
/ Not yet recruitingNot Applicable 琥珀酰明胶注射液用于择期手术急性等容性血液稀释(ANH)的多中心、区组随机、单盲、阳性药对照的有效性和安全性的等效临床研究
[Translation] A multicenter, block-randomized, single-blind, positive-controlled clinical study on the efficacy and safety of succinylated gelatin injection for acute isovolumetric hemodilution (ANH) in elective surgery
预实验：收集试验药物和对照药物用于择期手术急性等容性血液稀释(ANH)的有效性和安全性数据，为正式试验的设计和开展提供依据。
正式试验：比较试验药物和对照药物用于择期手术急性等容性血液稀释(ANH)的有效性和安全性，以评价两种制剂的临床等效性。
[Translation] Preliminary experiment: Collect the efficacy and safety data of the test drug and the control drug for acute isovolumetric hemodilution (ANH) in elective surgery to provide a basis for the design and implementation of the formal trial.
Formal trial: Compare the efficacy and safety of the test drug and the control drug for acute isovolumetric hemodilution (ANH) in elective surgery to evaluate the clinical equivalence of the two preparations.
/ CompletedNot Applicable 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 progesterone injection in healthy Chinese postmenopausal women
主要目的：观察单次皮下注射受试制剂黄体酮注射液与参比制剂（商品名：Lubion）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 progesterone injection and the reference preparation (trade name: Lubion) in healthy Chinese postmenopausal women, and to evaluate the bioequivalence and intra-individual variability between the two preparations of a single subcutaneous injection of progesterone injection. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese postmenopausal women
100 Clinical Results associated with Beijing Liuhuan Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Beijing Liuhuan Pharmaceutical Co., Ltd.
100 Deals associated with Beijing Liuhuan Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Beijing Liuhuan Pharmaceutical Co., Ltd.
