痔瘘熏洗颗粒治疗混合痔术后并发症(疼痛、水肿)的安全性与有效性的随机、双盲、安慰剂对照、多中心Ⅱ期临床研究
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical study on the safety and efficacy of hemorrhoids and fistula fumigation granules in the treatment of postoperative complications (pain and edema) of mixed hemorrhoids
初步评价痔瘘熏洗颗粒治疗混合痔术后并发症(疼痛、水肿)的安全性和有效性。
[Translation] To preliminarily evaluate the safety and efficacy of hemorrhoid fumigation granules in the treatment of postoperative complications (pain, edema) of mixed hemorrhoids.
/ Not yet recruitingPhase 1 SZ2726 片在健康受试者中单次、多次给药的安全性、耐受性、药代和药效动力学特征及食物影响的Ⅰ期临床研究
[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics and food effects of single and multiple doses of SZ2726 tablets in healthy subjects
主要目的:
评价 SZ2726 片在健康受试者中单次、多次给药后的安全性和耐受性。
次要目的:
1) 评价 SZ2726 片在健康受试者中单次、多次给药后的药代动力学(PK)特征;
2) 评价食物对 SZ2726 片 PK 特征的影响。
探索性目的:
1) 评价 SZ2726 片在健康受试者中单次、多次给药后的药效动力学(PD)特征;
2) 评价 SZ2726 片对 QT/QTc 间期的影响;
3) 探索 SZ2726 片口服给药后可能的代谢产物。
[Translation] Primary objective:
To evaluate the safety and tolerability of SZ2726 tablets after single and multiple administration in healthy subjects.
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) characteristics of SZ2726 tablets after single and multiple administration in healthy subjects;
2) To evaluate the effect of food on the PK characteristics of SZ2726 tablets.
Exploratory objectives:
1) To evaluate the pharmacodynamic (PD) characteristics of SZ2726 tablets after single and multiple administration in healthy subjects;
2) To evaluate the effect of SZ2726 tablets on the QT/QTc interval;
3) To explore the possible metabolites of SZ2726 tablets after oral administration.
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