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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Active, not recruitingPhase 1 一项在健康受试者中评价TG103注射液对缬沙坦胶囊、华法林钠片、阿托伐他汀钙片和地高辛片的药代动力学影响的I期临床试验
[Translation] A Phase I clinical trial evaluating the effect of TG103 injection on the pharmacokinetics of valsartan capsules, warfarin sodium tablets, atorvastatin calcium tablets, and digoxin tablets in healthy subjects
主要目的:
队列1:在中国健康受试者中评价TG103注射液对缬沙坦胶囊和华法林钠片的药代动力学(Pharmacokinetics,PK)影响。
队列2:在中国健康受试者中评价TG103注射液对阿托伐他汀钙片和地高辛片的PK影响。
次要目的:
队列1:在中国健康受试者中评价TG103注射液多次给药的PK特征和免疫原性;评价TG103注射液对华法林钠片药效动力学(Pharmacodynamics,PD)的影响;TG103注射液、缬沙坦胶囊和华法林钠片的安全性和耐受性;初步探索中国健康受试者中TG103注射液对QTc间期的影响。
队列2:在中国健康受试者中评价TG103注射液多次给药的PK特征和免疫原性;评价TG103注射液、阿托伐他汀钙片和地高辛片的安全性和耐受性。
[Translation] Primary objectives:
Cohort 1: To evaluate the effect of TG103 injection on the pharmacokinetics (PK) of valsartan capsules and warfarin sodium tablets in healthy Chinese subjects.
Cohort 2: To evaluate the effect of TG103 injection on the PK of atorvastatin calcium tablets and digoxin tablets in healthy Chinese subjects.
Secondary objectives:
Cohort 1: To evaluate the PK characteristics and immunogenicity of TG103 injection after multiple administration in healthy Chinese subjects; to evaluate the effect of TG103 injection on the pharmacodynamics (PD) of warfarin sodium tablets; the safety and tolerability of TG103 injection, valsartan capsules and warfarin sodium tablets; to preliminarily explore the effect of TG103 injection on the QTc interval in healthy Chinese subjects.
Cohort 2: To evaluate the PK characteristics and immunogenicity of TG103 injection after multiple administration in healthy Chinese subjects; to evaluate the safety and tolerability of TG103 injection, atorvastatin calcium tablets and digoxin tablets.
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.
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