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MechanismNLRP3 inhibitors |
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Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
随机、双盲、安慰剂对照评价柚皮苷片在健康受试者中多次给药的安全性及药代动力学I期研究
[Translation] A randomized, double-blind, placebo-controlled phase I study to evaluate the safety and pharmacokinetics of repeated administration of naringin tablets in healthy subjects
主要研究目的:在中国健康受试者中,评价柚皮苷片多次给药后的安全性。 次要研究目的:在中国健康受试者中,评价柚皮苷片多次给药后柚皮苷及代谢物柚皮 素的药代动力学特征。 探索性研究目的:在中国健康受试者中,进行柚皮苷片多次给药后的肠道菌群代谢研 究。
[Translation] Primary study objective: To evaluate the safety of naringin tablets after multiple administration in healthy Chinese subjects. Secondary study objective: To evaluate the pharmacokinetic characteristics of naringin and its metabolite naringenin after multiple administration in healthy Chinese subjects. Exploratory study objective: To study the intestinal flora metabolism of naringin tablets after multiple administration in healthy Chinese subjects.
评价柚皮苷片剂单次给药/进食影响在健康受试者中的安全性、耐受性及药代动力学的I期研究
[Translation] A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Naringin Tablets after Single Dose/Food Administration in Healthy Subjects
1. 评价中国健康受试者口服柚皮苷片单次剂量递增后的安全性、耐受性。 2. 评价单次剂量递增口服柚皮苷片后,柚皮苷及代谢物柚皮素的药代动力学特征。 3. 评价中国健康受试者空腹或进食标准试验餐后口服柚皮苷片,进食对柚皮苷和代谢物柚皮素对 人体药代动力学特征的影响。
[Translation] 1. To evaluate the safety and tolerability of naringin tablets after single-dose escalation in healthy Chinese subjects. 2. To evaluate the pharmacokinetic characteristics of naringin and its metabolite naringenin after single-dose escalation in healthy Chinese subjects. 3. To evaluate the effect of food on the pharmacokinetic characteristics of naringin and its metabolite naringenin after oral administration of naringin tablets on an empty stomach or after a standard test meal in healthy Chinese subjects.
100 Clinical Results associated with Guangdong Zhongda Tianyi Biological Technology Development Co., Ltd.
0 Patents (Medical) associated with Guangdong Zhongda Tianyi Biological Technology Development Co., Ltd.
100 Deals associated with Guangdong Zhongda Tianyi Biological Technology Development Co., Ltd.
100 Translational Medicine associated with Guangdong Zhongda Tianyi Biological Technology Development Co., Ltd.