2
Clinical Trials associated with YZJ-1495评价YZJ-1495盐酸盐胶囊多次给药安全性、耐受性和药代动力学特征的Ib期临床试验
[Translation] Phase Ib clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of YZJ-1495 hydrochloride capsules after repeated administration
主要目的:
1) 评价YZJ-1495盐酸盐胶囊多次给药的耐受性及安全性;
2) 评价YZJ-1495盐酸盐胶囊多次给药后YZJ-1495及其代谢产物的药代动力学特征。
次要目的:
初步评价YZJ-1495盐酸盐胶囊治疗带状疱疹后神经痛(PHN)的有效性。
[Translation] Main objectives:
1) To evaluate the tolerability and safety of multiple administrations of YZJ-1495 hydrochloride capsules;
2) To evaluate the pharmacokinetic characteristics of YZJ-1495 and its metabolites after multiple administrations of YZJ-1495 hydrochloride capsules.
Secondary objectives:
To preliminarily evaluate the effectiveness of YZJ-1495 hydrochloride capsules in the treatment of postherpetic neuralgia (PHN).
YZJ-1495盐酸盐胶囊在健康受试者中的药代动力学研究及食物影响研究
[Translation] Pharmacokinetics and food effect study of YZJ-1495 hydrochloride capsules in healthy subjects
1. 评价YZJ-1495盐酸盐胶囊单剂空腹给药剂量递增在健康受试者中的耐受性及安全性;
2. 评价YZJ-1495盐酸盐胶囊单剂空腹给药剂量递增在健康受试者中YZJ-1495及其代谢产物的药代动力学特征;
3. 评价食物对健康受试者服用YZJ-1495盐酸盐胶囊后YZJ-1495及其代谢产物的药代动力学的影响;
4. 评价食物对健康受试者服用YZJ-1495盐酸盐胶囊后安全性影响;
5. 考察健康受试者单剂空腹口服YZJ-1495盐酸盐胶囊后YZJ-1495及其代谢产物的尿样、粪样累积排出率;
6. 考察YZJ-1495盐酸盐胶囊单剂空腹给药剂量递增在健康受试者中药物浓度-QT间期(C-QT)变化关系及对心电图QT间期的影响。
[Translation] 1. To evaluate the tolerability and safety of single-dose escalating fasting doses of YZJ-1495 hydrochloride capsules in healthy subjects;
2. To evaluate the pharmacokinetic characteristics of YZJ-1495 and its metabolites in healthy subjects after single-dose escalating fasting doses of YZJ-1495 hydrochloride capsules;
3. To evaluate the effect of food on the pharmacokinetics of YZJ-1495 and its metabolites after healthy subjects took YZJ-1495 hydrochloride capsules;
4. To evaluate the effect of food on the safety of healthy subjects after taking YZJ-1495 hydrochloride capsules;
5. To investigate the cumulative excretion rate of YZJ-1495 and its metabolites in urine and feces after single-dose fasting oral administration of YZJ-1495 hydrochloride capsules in healthy subjects;
6. To investigate the relationship between drug concentration and QT interval (C-QT) and the effect on the QT interval of electrocardiogram after single-dose escalating fasting doses of YZJ-1495 hydrochloride capsules in healthy subjects.
100 Clinical Results associated with YZJ-1495
100 Translational Medicine associated with YZJ-1495
100 Patents (Medical) associated with YZJ-1495
100 Deals associated with YZJ-1495