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COMPLETED
NCT07799090
PHASE1

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.

View on ClinicalTrials.gov

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

DRUG

GB-5001A 280 mg long acting Injection

Depending on the cohort, doses will be varied to administer.

DRUG

Aricept® 5 mg film-coated tablet

Aricept® (donepezil hydrochloride) 5 mg film-coated tablet administered orally as an active comparator

DRUG

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