一项评估泊沙康唑肠溶片冲击疗法治疗甲真菌病的有效性和安全性的多中心、随机、双盲、安慰剂对照的Ⅲ期临床研究
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial evaluating the efficacy and safety of posaconazole enteric-coated tablets pulse therapy for onychomycosis.
评估泊沙康唑肠溶片冲击疗法治疗甲真菌病的有效性和安全性
[Translation] Evaluation of the efficacy and safety of posaconazole enteric-coated tablet pulse therapy for onychomycosis.
一项评价FH001片在健康受试者中单次及多次给药的安全性、耐受性、药代动力学特征和食物影响的Ⅰ期临床研究
[Translation] A phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and food effects of single and multiple doses of FH001 tablets in healthy subjects.
主要研究目的
Part A:评价健康受试者单次口服FH001片的安全性和耐受性。
Part B:评价食物对健康受试者单次口服FH001片后的药代动力学(PK)特征影响。
Part C:评价健康受试者多次口服FH001片的安全性和耐受性。
次要研究目的
Part A:
评价健康受试者单次口服FH001片的PK特征;
评价健康受试者单次口服不同剂量FH001片情况下对QTc间期影响。
Part B:
评价在空腹和餐后状态下,健康受试者单次口服FH001片的安全性和耐受性。
Part C:
评价健康受试者单次和多次口服FH001片的PK特征;
评价健康受试者单次和多次口服不同剂量FH001片情况下对QTc间期影响。
探索性目的
Part A:评价健康受试者单次口服FH001片后的药效特征。
Part C:评价健康受试者多次口服FH001片后尿液PK特征。
在选定剂量下,如数据允许,鉴定FH001的代谢产物。
[Translation] Primary Research Objectives
Part A: To evaluate the safety and tolerability of a single oral dose of FH001 tablets in healthy subjects.
Part B: To evaluate the effect of food on the pharmacokinetic (PK) characteristics of a single oral dose of FH001 tablets in healthy subjects.
Part C: To evaluate the safety and tolerability of multiple oral doses of FH001 tablets in healthy subjects.
Secondary Research Objectives
Part A: To evaluate the PK characteristics of a single oral dose of FH001 tablets in healthy subjects;
To evaluate the effect of different single oral doses of FH001 tablets on the QT interval in healthy subjects.
Part B: To evaluate the safety and tolerability of a single oral dose of FH001 tablets in healthy subjects under fasting and postprandial conditions.
Part C: To evaluate the PK characteristics of single and multiple oral doses of FH001 tablets in healthy subjects;
To evaluate the effect of different single and multiple oral doses of FH001 tablets on the QT interval in healthy subjects.
Exploratory Objectives
Part A: To evaluate the pharmacodynamic characteristics of a single oral dose of FH001 tablets in healthy subjects.
Part C: Evaluate the urinary pharmacokinetic characteristics of healthy subjects after multiple oral administrations of FH001 tablets.
Identify the metabolites of FH001 at selected doses, if data permit.
一项在中国健康参与者中评价食物对谷美替尼片的药代动力学特性和安全性影响的临床研究
[Translation] A clinical study evaluating the effects of food on the pharmacokinetic properties and safety of gumetinib tablets in healthy Chinese participants.
主要研究目的 评价低脂餐对健康参与者口服谷美替尼片后药代动力学的影响。
次要研究目的 评估健康参与者在空腹以及进食低脂餐状态下口服谷美替尼片的药代动力学特征;
评估健康参与者在空腹以及进食低脂餐状态下口服谷美替尼片的安全性和耐受性。
[Translation] Primary objective: To evaluate the effect of a low-fat meal on the pharmacokinetics of gumetinib tablets after oral administration in healthy participants.
Secondary objectives: To assess the pharmacokinetic characteristics of gumetinib tablets after oral administration in healthy participants under fasting and low-fat meal conditions; and to assess the safety and tolerability of gumetinib tablets after oral administration in healthy participants under fasting and low-fat meal conditions.
100 Clinical Results associated with Jiangsu Xuantai Pharmaceutical Co., Ltd
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100 Translational Medicine associated with Jiangsu Xuantai Pharmaceutical Co., Ltd