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Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

AD Clinical Trial

Official title:
Evaluation of Safety and Pharmacokinetic Profiles of a Single-dose HHT201 in Healthy Subjects

Clinical Trial Summary

The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.

Clinical Trial Description

The study aims to evaluate the safety, pharmacokinetics and to determine the potential dose limiting toxicity of HHT201 in healthy subjects between the ages of 20-59, 6 in 17mg dose group and 20 in 34mg dose group. Another 12 subjects will be administered a tablet of 5mg Donepezil Hydrochloride to get the PK profile of Donepezil as reference. Eligible subjects will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical, physical examination, and routine laboratory assessment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03932916
Study type Interventional
Source Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date July 2, 2019
Completion date September 11, 2020
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