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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

NCT07799090 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-09-02

No results posted yet for this study

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.

Conditions

  • Bioavailability Study on Healthy Volunteers

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

Sponsors & Collaborators

  • PT Equilab International

    collaborator INDUSTRY

  • G2GBio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2026-04-15
Completion
2026-04-15

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07799090 on ClinicalTrials.gov