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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date24 Sep 1996 |
一项评价CPL-01用于单侧第一跖骨远端拇囊炎切除伴截骨术后镇痛的有效性和安全性的随机、双盲、安慰剂和阳性对照研究
[Translation] A randomized, double-blind, placebo- and active-controlled study to evaluate the efficacy and safety of CPL-01 for postoperative analgesia after unilateral distal first metatarsal bunionectomy with osteotomy
主要目的:评价与安慰剂相比,CPL-01在拇囊炎切除术受试者中的有效性
次要目的:评价与阳性对照药相比,CPL-01在研究人群中的有效性
[Translation] Primary objective: To evaluate the efficacy of CPL-01 compared to placebo in subjects undergoing bunionectomy Secondary objective: To evaluate the efficacy of CPL-01 compared to an active comparator in the study population
一项评价CPL-01用于开放性腹股沟疝修补术后镇痛的有效性和安全性的随机、双盲、安慰剂和阳性对照研究
[Translation] A randomized, double-blind, placebo- and active-controlled study to evaluate the efficacy and safety of CPL-01 for postoperative analgesia after open inguinal hernia repair
本研究是一项随机、双盲、安慰剂和阳性对照的III期研究,旨在评价与安慰剂和盐酸罗哌卡因(耐乐品®或等效仿制药)相比,CPL-01用于开放性腹股沟疝补片修补术后镇痛的有效性、安全性和耐受性及药代动力学(PK)。此外,本研究还包含一项中国特定的开放性PK子研究。
[Translation] This study is a randomized, double-blind, placebo- and active-controlled Phase III study designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of CPL-01 for postoperative analgesia after open inguinal hernia mesh repair compared with placebo and ropivacaine hydrochloride (Naropine® or equivalent generic drug). In addition, this study also includes a China-specific open-label PK sub-study.
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