Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male Volunteers

Summary

This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM depot in healthy male volunteers. And, it is to predict the multiple-dose pharmacokinetics based on the single-dose pharmacokinetics of GB-5001 IM depot and the oral Aricept® (donepezil hydrochloride) tablet by PK modeling.

Timeline

Start

2022-08-26

Primary completion

2023-06-02

Completion

2023-06-02

Publications

• Khwarg J, Lee H, Yu KS, Seol E, Chung JY. Population Pharmacokinetic Modeling and Simulation for Dose Optimization of GB-5001, a Long-Acting Intramuscular Injection of Donepezil, in Healthy Participants. Neurol Ther. 2024 Oct;13(5):1453-1466. doi: 10.1007/s40120-024-00643-4. Epub 2024 Aug 10.

Drugs

Indications