评价孟鲁司特钠凝胶在痔疮手术患者中的安全性和耐受性、药代动力学特征及有效性的多中心、随机、双盲、安慰剂对照IIa期临床研究
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase IIa clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics and efficacy of montelukast sodium gel in patients undergoing hemorrhoid surgery
主要目的:评价不同剂量孟鲁司特钠凝胶用于痔疮手术患者的安全性和耐受性。
次要目的:评价不同剂量孟鲁司特钠凝胶改善痔疮手术患者症状的疗效;评价孟鲁司特钠凝胶在痔疮手术患者中的药代动力学(PK)特征;探索孟鲁司特钠凝胶在痔疮手术患者中的III期临床推荐剂量。
[Translation] Primary objective: To evaluate the safety and tolerability of different doses of montelukast sodium gel in patients undergoing hemorrhoid surgery.
Secondary objective: To evaluate the efficacy of different doses of montelukast sodium gel in improving symptoms in patients undergoing hemorrhoid surgery; to evaluate the pharmacokinetic (PK) characteristics of montelukast sodium gel in patients undergoing hemorrhoid surgery; to explore the recommended dose of montelukast sodium gel in Phase III clinical trials in patients undergoing hemorrhoid surgery.
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