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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date01 Jan 1994 |
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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
HZ-J001乳膏治疗非节段型白癜风患者的有效性和安全性的多中心、随机、双盲、安慰剂对照II期临床试验
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial on the efficacy and safety of HZ-J001 cream in the treatment of patients with non-segmental vitiligo
初步评估不同规格HZ-J001乳膏治疗非节段型白癜风的有效性和安全性;评估HZ-J001乳膏在非节段型白癜风患者的系统暴露
[Translation] To preliminarily evaluate the efficacy and safety of HZ-J001 cream of different strengths in the treatment of non-segmental vitiligo; to evaluate the systemic exposure of HZ-J001 cream in patients with non-segmental vitiligo
评估HZ-J001乳膏在健康志愿者中单次和多次给药的安全性/耐受性、药代动力学特征的随机、双盲、安慰剂对照的Ia期临床试验
[Translation] A randomized, double-blind, placebo-controlled Phase Ia clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics of single and multiple doses of HZ-J001 cream in healthy volunteers
主要目的:评估HZ-J001乳膏在健康成年受试者中的安全性和耐受性,为确定后期试验所采用的给药剂量及面积提供安全性依据。
次要目的:评估1.0%、1.5%、2.0% HZ-J001乳膏在健康成年受试者中单次和多次局部皮肤给药的系统暴露水平和药代动力学特征。
[Translation] Primary objective: To evaluate the safety and tolerability of HZ-J001 cream in healthy adult subjects, and to provide a safety basis for determining the dosage and area of administration used in later trials.
Secondary objective: To evaluate the systemic exposure level and pharmacokinetic characteristics of 1.0%, 1.5%, and 2.0% HZ-J001 cream in healthy adult subjects after single and multiple topical skin administration.
[Translation] Comparative study on the pharmacokinetics of desonide cream in human body
以湖北人福成田药业有限公司生产的地奈德乳膏为受试制剂,Perrigo New York Inc 持证的地奈
德乳膏(0.05%,Perrigo®)为参比制剂,研究局部给药后受试制剂与参比制剂的体内暴露量比,从
而评价受试制剂的安全性。
[Translation] The desonide cream produced by Hubei Renfu Chengtian Pharmaceutical Co., Ltd. was used as the test preparation, and the desonide cream (0.05%, Perrigo®) certified by Perrigo New York Inc. was used as the reference preparation. The in vivo exposure ratio of the test preparation and the reference preparation after local administration was studied to evaluate the safety of the test preparation.
100 Clinical Results associated with Hubei Renfu Chengtian Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hubei Renfu Chengtian Pharmaceutical Co., Ltd.
100 Deals associated with Hubei Renfu Chengtian Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hubei Renfu Chengtian Pharmaceutical Co., Ltd.