/ Active, not recruitingPhase 2 评价GBI268注射液单次局部注射用于痔疮切除患者术后镇痛或术中麻醉的有效性和安全性的一项多中心、随机、双盲、阳性药对照II期临床试验
[Translation] A multicenter, randomized, double-blind, active-controlled phase II clinical trial evaluating the efficacy and safety of a single local injection of GBI268 for postoperative analgesia or intraoperative anesthesia in patients undergoing hemorrhoidectomy.
主要目的:评价GBI268注射液单次局部注射用于痔疮切除患者术后镇痛或术中麻醉的有效性。
次要目的:1)评价GBI268注射液单次局部注射用于痔疮切除患者术后镇痛或术中麻醉的安全性。
2)评价GBI268注射液单次局部注射用于痔疮切除患者术后镇痛的药代动力学特征。
[Translation] Primary objective: To evaluate the efficacy of a single local injection of GBI268 injection for postoperative analgesia or intraoperative anesthesia in patients undergoing hemorrhoidectomy.
Secondary objectives: 1) To evaluate the safety of a single local injection of GBI268 injection for postoperative analgesia or intraoperative anesthesia in patients undergoing hemorrhoidectomy.
2) To evaluate the pharmacokinetic characteristics of a single local injection of GBI268 injection for postoperative analgesia in patients undergoing hemorrhoidectomy.
一项多中心、随机、双盲、阳性药和安慰剂平行对照评价GBI268注射液单次给药用于开放式单侧拇外翻矫形手术受试者的有效性、安全性和药代动力学特征研究
[Translation] A multicenter, randomized, double-blind, active drug and placebo parallel controlled study to evaluate the efficacy, safety and pharmacokinetic characteristics of a single dose of GBI268 injection in subjects undergoing open unilateral hallux valgus correction surgery
1.评估GBI268单次给药用于开放式单侧拇外翻矫形手术术后镇痛的有效性。
2.探索GBI268单次给药用于开放式单侧拇外翻矫形手术术后镇痛的合理剂量。
3.评价GBI268单次给药用于开放式单侧拇外翻矫形手术术后镇痛的安全性。
4.评价GBI268单次给药用于开放式单侧拇外翻矫形手术术后镇痛的药代动力学(PK)特征。
[Translation] 1. To evaluate the effectiveness of a single administration of GBI268 for postoperative analgesia in open unilateral hallux valgus surgery.
2. To explore the reasonable dose of GBI268 for postoperative analgesia in open unilateral hallux valgus surgery.
3. To evaluate the safety of a single administration of GBI268 for postoperative analgesia in open unilateral hallux valgus surgery.
4. To evaluate the pharmacokinetic (PK) characteristics of a single administration of GBI268 for postoperative analgesia in open unilateral hallux valgus surgery.
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