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Pharmacokinetic Study of GB-5001A 280 mg Long Acting Injection, in Comparison With the Comparator Drug Aricept® 5 mg and Aricept® 10 mg Film-coated Tablet in Healthy Subjects
Sponsor: G2GBio, Inc.
Summary
This study is to find out whether the bioavailability of GB-5001A 280 mg Injection is compared to the comparator drug of Aricept® 5 mg and Aricept® 10 mg which are Film-Coated Tablet when administered in healthy subjects. Also to monitor the adverse events and to ensure the safety of the subjects.
Official title: Pilot Pharmacokinetic Study of GB-5001A 280 mg Long Acting Injection, in Comparison With the Comparator Drug Aricept® 5 mg and Aricept® 10 mg Film-coated Tablet in Healthy Subjects
Key Details
Gender
MALE
Age Range
19 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2025-08-12
Completion Date
2026-04-15
Last Updated
2026-09-02
Healthy Volunteers
Yes
Interventions
GB-5001A 280 mg long acting Injection
Depending on the cohort, doses will be varied to administer.
Aricept® 5 mg film-coated tablet
Aricept® (donepezil hydrochloride) 5 mg film-coated tablet administered orally as an active comparator
Aricept® 10 mg film-coated tablet
Aricept® (donepezil hydrochloride) 10 mg film-coated tablet administered orally as an active comparator
Locations (1)
PT Equilab International
Jakarta, South Jakarta, Indonesia