NCT03932916

Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Shanghai Synergy Pharmaceutical Sciences Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 59 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• AD

Interventions

Type	Name	Description
DRUG	Donepezil Pamoate for Injection 17mg	A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
DRUG	Donepezil Pamoate for Injection 34mg	A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
DRUG	Donepezil Hydrochloride 5mg	A tablet of 5mg Donepezil Hydrochloride will be administered once.

Timeline

• Start date: 2019-07-02
• Primary completion: 2020-08-06
• Completion: 2020-09-11
• First posted: 2019-05-01
• Last updated: 2020-09-29

Locations

1 site across 1 country: China