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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date08 Aug 1973 |
/ Not yet recruitingPhase 1 不同剂量注射用双氯芬酸钠在中国健康成年受试者中多次静脉推注的药代动力学特征及安全性的单中心、随机、双盲、安慰剂
平行对照Ⅰb期临床研究
[Translation] A single-center, randomized, double-blind, placebo-controlled phase Ib clinical study on the pharmacokinetic characteristics and safety of multiple intravenous injections of different doses of diclofenac sodium for injection in healthy Chinese adult subjects
主要研究目的:
评价多次静脉推注不同剂量的注射用双氯芬酸钠在中国健康成年受试者体内的药代动力学(PK)特征。
次要研究目的:
初步评价多次静脉推注不同剂量的注射用双氯芬酸钠后中国健康成年受试者的安全性。
[Translation] Main study objectives:
To evaluate the pharmacokinetic (PK) characteristics of diclofenac sodium for injection in healthy Chinese adult subjects after multiple intravenous injections of different doses.
Secondary study objectives:
To preliminarily evaluate the safety of diclofenac sodium for injection in healthy Chinese adult subjects after multiple intravenous injections of different doses.
一项评估不同剂量注射用双氯芬酸钠在健康成年受试者中单次静脉推注的耐受性、安全性及药代动力学特征的单中心、双盲、随机、安慰剂平行对照Ia期临床研究
[Translation] A single-center, double-blind, randomized, placebo-controlled phase Ia clinical study to evaluate the tolerability, safety and pharmacokinetic characteristics of a single intravenous bolus of different doses of diclofenac sodium for injection in healthy adult subjects
主要目的:
? 初步评价单次静脉推注不同剂量注射用双氯芬酸钠后健康成年受试者的耐受性和安全性。
次要目的:
评价单次静脉推注不同剂量的注射用双氯芬酸钠在健康成年受试者体内的药代动力学(PK)特征。
[Translation] Primary objective:
? To preliminarily evaluate the tolerability and safety of different doses of diclofenac sodium for injection in healthy adult subjects after a single intravenous push.
Secondary objective:
To evaluate the pharmacokinetic (PK) characteristics of different doses of diclofenac sodium for injection in healthy adult subjects after a single intravenous push.
100 Clinical Results associated with Jiangsu Simiao Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Jiangsu Simiao Pharmaceutical Technology Co., Ltd.
100 Deals associated with Jiangsu Simiao Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Jiangsu Simiao Pharmaceutical Technology Co., Ltd.