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Mechanismthrombin inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Inactive Indication- |
Drug Highest PhaseIND Approval |
First Approval Ctry. / Loc.- |
First Approval Date- |
A Single-center, Open-label, Single-dose Ascending Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Profile of HHT201 (Donepezil Dihydroxynaphthalate for Injection) in Healthy Subjects
The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.
一项评价HHT120胶囊在健康受试者中的安全性、耐受性、药代动力学及药效动力学特征的单次、多次给药剂量递增及食物对PK影响的I期临床研究
[Translation] A phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of HHT120 capsules in healthy subjects with single and multiple dose escalations and the impact of food on PK
主要研究目的:
评价健康受试者单次及多次服用HHT120胶囊后的安全性、耐受性。
次要研究目的:
评价健康受试者单次及多次服用HHT120胶囊后的药代动力学特征;
评价健康受试者单次及多次服用HHT120胶囊后的药效动力学特征;
评价健康受试者单次及多次服用HHT120胶囊后血药浓度与药效动力学的相关性;
评价健康受试者空腹及餐后状态下服用HHT120胶囊的药代动力学特征,评价食物对药代动力学特征的影响。
探索性目的:
健康受试者单次服用HHT120胶囊后人体内的主要代谢产物鉴定;
健康受试者单次及多次服用HHT120胶囊后对QT间期的影响。
[Translation] Main research purposes:
To evaluate the safety and tolerability of HHT120 capsules in healthy subjects after single and multiple doses.
Secondary research purpose:
To evaluate the pharmacokinetic characteristics of HHT120 capsules in healthy subjects after single and multiple doses;
To evaluate the pharmacodynamic characteristics of HHT120 capsules in healthy subjects after single and multiple doses;
To evaluate the correlation between plasma concentration and pharmacodynamics of HHT120 capsules in healthy subjects after single and multiple doses;
To evaluate the pharmacokinetic characteristics of HHT120 capsules taken by healthy subjects under fasting and postprandial conditions, and to evaluate the impact of food on the pharmacokinetic characteristics.
Exploratory purpose:
Identification of the main metabolites in the human body after healthy subjects took a single dose of HHT120 capsules;
Effects on QT interval after single and multiple doses of HHT120 capsules in healthy subjects.
A Single and Multiple Assending Doses Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Characteristics and Food Effect After Administration of HHT120 Capsule in Healthy Subjects
This is a first in human clinical trial with HHT120. The purpose of this study is to characterize the safety, pharmacokinetic (PK) and Pharmacodynamic (PD) profile of single and multiple twice-daily doses of HHT120 in healthy Subjects and to assess the effects of food on the PK profile of single-dose of HHT120 in healthy Subjects.
100 Clinical Results associated with Shanghai Synergy Pharmaceutical Sciences Co., Ltd
0 Patents (Medical) associated with Shanghai Synergy Pharmaceutical Sciences Co., Ltd
Research progress of drugs affecting epigenetics in the treatment of inflammatory bowel disease
Author: Wu, Jianzhong ; Liu, Heng ; Wu, Qimei ; Yang, Xuqin ; Zhang, Chengqui ; Wu, Xiumei ; Zhang, Zhen ; Ge, Jian
100 Deals associated with Shanghai Synergy Pharmaceutical Sciences Co., Ltd
100 Translational Medicine associated with Shanghai Synergy Pharmaceutical Sciences Co., Ltd