|
|
|
|
|
Inactive Indication- |
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 evaluating the efficacy and safety of CPL-01 for postoperative pain relief after unilateral distal first metatarsal bunion resection 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 effectiveness of CPL-01 compared to placebo in subjects undergoing bunionectomy
Secondary objective: To evaluate the effectiveness of CPL-01 in the study population compared to the active control
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 evaluating the efficacy and safety of CPL-01 for 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 to evaluate CPL-01 compared with placebo and ropivacaine hydrochloride (Nauropin® or an equivalent generic Efficacy, safety and tolerability and pharmacokinetics (PK) of analgesia after open inguinal hernia mesh repair. In addition, this study included a China-specific open-label PK substudy.
100 Clinical Results associated with Jiali (Shenzhen) Biotechnology Co., Ltd.
0 Patents (Medical) associated with Jiali (Shenzhen) Biotechnology Co., Ltd.
100 Deals associated with Jiali (Shenzhen) Biotechnology Co., Ltd.
100 Translational Medicine associated with Jiali (Shenzhen) Biotechnology Co., Ltd.