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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项多中心、非随机、开放、平行对照、单次给药,评价TG103注射液在肾功能正常和肾功能不全受试者中的药代动力学特征的Ⅰ期临床试验
[Translation] A multicenter, non-randomized, open-label, parallel-controlled, single-dose phase I clinical trial to evaluate the pharmacokinetic characteristics of TG103 injection in subjects with normal renal function and renal insufficiency
主要目的:
评价肾功能正常和肾功能不全受试者单次皮下注射TG103注射液后的药代动力学特征。
次要目的:
评价肾功能正常和肾功能不全受试者单次皮下注射TG103注射液后的免疫原性; 评价肾功能正常和肾功能不全受试者单次皮下注射TG103注射液后的安全性和耐受性。
[Translation] Primary purpose:
To evaluate the pharmacokinetic characteristics of TG103 injection after a single subcutaneous injection in subjects with normal renal function and renal insufficiency.
Secondary purpose:
To evaluate the immunogenicity of TG103 injection after a single subcutaneous injection in subjects with normal renal function and renal insufficiency; To evaluate the safety and tolerability of TG103 injection after a single subcutaneous injection in subjects with normal renal function and renal insufficiency.
中国健康受试者不同部位皮下注射TG103注射液的生物利用度比较研究
[Translation] Comparative study on the bioavailability of TG103 injection in different subcutaneous sites in Chinese healthy subjects
主要目的:比较中国健康受试者在不同给药部位皮下注射TG103注射液的相对生物利用度(bioavailability, BA)。
次要目的:评价中国健康受试者不同给药部位皮下注射TG103注射液的免疫原性; 评价中国健康受试者不同给药部位皮下注射TG103注射液后的安全性 和耐受性。
[Translation] Primary objective: To compare the relative bioavailability (BA) of TG103 injection in Chinese healthy subjects after subcutaneous injection at different administration sites.
Secondary objective: To evaluate the immunogenicity of TG103 injection in Chinese healthy subjects after subcutaneous injection at different administration sites; To evaluate the safety and tolerability of TG103 injection in Chinese healthy subjects after subcutaneous injection at different administration sites.
在中国健康受试者中评价 TG103 注射液对盐酸二甲双胍片的药代动力学影响研究
[Translation] A study to evaluate the effect of TG103 injection on the pharmacokinetics of metformin hydrochloride tablets in Chinese healthy subjects
主要目的:在中国健康受试者中评价 TG103 注射液多次给药对盐酸二甲双胍片的 药代动力学(Pharmacokinetics,PK)影响。
次要目的:
在中国健康受试者中评价 TG103 注射液多次给药的 PK 特征; 在中国健康受试者中评价 TG103 注射液多次给药的免疫原性; 在中国健康受试者中评价 TG103 注射液和盐酸二甲双胍片多次给药后的安全性和耐受性。
[Translation] Primary objective: To evaluate the effect of multiple administration of TG103 injection on the pharmacokinetics (PK) of metformin hydrochloride tablets in Chinese healthy subjects.
Secondary objectives:
To evaluate the PK characteristics of multiple administration of TG103 injection in Chinese healthy subjects; To evaluate the immunogenicity of multiple administration of TG103 injection in Chinese healthy subjects; To evaluate the safety and tolerability of TG103 injection and metformin hydrochloride tablets after multiple administration in Chinese healthy subjects.
100 Clinical Results associated with Chengdu Tianshizhen Biotechnology Co., Ltd.
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100 Translational Medicine associated with Chengdu Tianshizhen Biotechnology Co., Ltd.