/ CompletedNot Applicable 布美他尼片在健康研究参与者中的单剂量、随机、开放、交叉、两制剂、两周期餐后人体生物等效性试验
[Translation] A single-dose, randomized, open-label, crossover, two-dose, two-period fed human bioequivalence study of bumetanide tablets in healthy study participants
主要目的:以成都新恒创药业有限公司的布美他尼片(规格:1mg)为受试制剂,以Karo Pharma AB的布美他尼片(规格:1mg)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康人体中的安全性。
[Translation] Primary objective: Using bumetanide tablets (specification: 1 mg) of Chengdu Xinhengchuang Pharmaceutical Co., Ltd. as the test preparation and bumetanide tablets (specification: 1 mg) of Karo Pharma AB as the reference preparation, the bioequivalence of the two preparations in healthy humans was investigated according to the relevant provisions of the bioequivalence test.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy humans.
/ CompletedNot Applicable 布美他尼片在健康研究参与者中的单剂量、随机、开放、交叉、两制剂、两周期空腹人体生物等效性试验
[Translation] A single-dose, randomized, open-label, crossover, two-dose, two-period fasting human bioequivalence study of bumetanide tablets in healthy study participants
主要目的:以成都新恒创药业有限公司的布美他尼片(规格:1mg)为受试制剂,以Karo Pharma AB的布美他尼片(规格:1mg)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康人体中的安全性。
[Translation] Primary objective: Using bumetanide tablets (specification: 1 mg) of Chengdu Xinhengchuang Pharmaceutical Co., Ltd. as the test preparation and bumetanide tablets (specification: 1 mg) of Karo Pharma AB as the reference preparation, the bioequivalence of the two preparations in healthy humans was investigated according to the relevant provisions of the bioequivalence test.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy humans.
/ CompletedNot Applicable 肌内注射鲑降钙素注射液在成年健康绝经期女性研究参与者中的单剂量、随机、开放、两制剂、两序列、四周期交叉的药代动力学/药效动力学比对研究
[Translation] A single-dose, randomized, open-label, two-formulation, two-sequence, four-period crossover pharmacokinetic/pharmacodynamic comparison study of intramuscular salmon calcitonin injection in healthy adult menopausal female study participants
以成都欣捷高新技术开发股份有限公司的鲑降钙素注射液(规格:1mL:8.3μg(50IU))为受试制剂,以Future Health Pharma GmbH.的鲑降钙素注射液(商品名:Miacalcic®/密盖息®,规格:1mL:50IU)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的药代动力学/药效动力学特征。
[Translation] The salmon calcitonin injection (specification: 1mL: 8.3μg (50IU)) of Chengdu Xinjie High-tech Development Co., Ltd. was used as the test preparation, and the salmon calcitonin injection (trade name: Miacalcic®, specification: 1mL: 50IU) of Future Health Pharma GmbH was used as the reference preparation. According to the relevant provisions of the bioequivalence study, the pharmacokinetic/pharmacodynamic characteristics of the two preparations in healthy humans were investigated.
100 Clinical Results associated with Chengdu Giantech Hi-Technology Development Co., Ltd.
0 Patents (Medical) associated with Chengdu Giantech Hi-Technology Development Co., Ltd.
100 Deals associated with Chengdu Giantech Hi-Technology Development Co., Ltd.
100 Translational Medicine associated with Chengdu Giantech Hi-Technology Development Co., Ltd.