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Drug Highest PhaseApproved |
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First Approval Date03 Jul 1992 |
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Drug Highest PhaseNDA/BLA |
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Drug Highest PhasePhase 1 |
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锝[99mTc]异腈葡萄糖注射液在健康受试者体内的药代动力学和安全性的I期临床研究
[Translation] Phase I clinical study on the pharmacokinetics and safety of technetium [99mTc] isonitrile glucose injection in healthy volunteers
主要目的:
检测试验药物在健康受试者体内的药代动力学,以及在人体内的生物分布及估算内照射辐射吸收剂量,为II期临床研究方案设计提供依据。
次要目的
观察试验药物对健康受试者的安全性。
[Translation] Main purpose:
To detect the pharmacokinetics of the test drug in healthy subjects, as well as its biodistribution in the human body and estimate the internal radiation absorption dose, so as to provide a basis for the design of the Phase II clinical study.
Secondary purpose
To observe the safety of the test drug in healthy subjects.
注射用亚锡半乳糖酰人血清白蛋白二亚乙基三胺五乙酸盐用于肝脏功能评估的有效性和安全性研究
[Translation] Efficacy and safety of stannous galactosyl human serum albumin diethylenetriamine pentaacetate for injection in liver function assessment
主要目的:评价注射用亚锡半乳糖酰人血清白蛋白二亚乙基三胺五乙酸盐用于临床肝功能评估的有效性;
次要目的:评价注射用亚锡半乳糖酰人血清白蛋白二亚乙基三胺五乙酸盐用于肝功能评估的安全性。
[Translation] Primary objective: To evaluate the effectiveness of stannous galactosyl human serum albumin diethylenetriamine pentaacetate for injection in clinical liver function assessment;
Secondary objective: To evaluate the safety of stannous galactosyl human serum albumin diethylenetriamine pentaacetate for injection in liver function assessment.
99mTc-GSA注射液在中国健康志愿者体内的药代动力学和安全性的I期临床研究
[Translation] Phase I clinical study on the pharmacokinetics and safety of 99mTc-GSA injection in Chinese healthy volunteers
主要目的:评估锝[99mTc]半乳糖酰人血清白蛋白二亚乙基三胺五乙酸盐(99mTc-GSA)注射液在健康志愿者体内的药代动力学特征; 次要目的:评估锝[99mTc]半乳糖酰人血清白蛋白二亚乙基三胺五乙酸盐(99mTc-GSA)注射液单次给药在健康受试者中的安全性和耐受性。
[Translation] Primary objective: To evaluate the pharmacokinetic characteristics of technetium [99mTc] galactosyl human serum albumin diethylenetriamine pentaacetate (99mTc-GSA) injection in healthy volunteers; Secondary objective: To evaluate the safety and tolerability of single-dose technetium [99mTc] galactosyl human serum albumin diethylenetriamine pentaacetate (99mTc-GSA) injection in healthy subjects.
100 Clinical Results associated with Beijing Shihong Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Beijing Shihong Pharmaceutical Co., Ltd.