Bioavailability Study on Healthy VolunteersPhase 1NCT07799090
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
A Phase 1 study testing GB-5001A 280 mg long acting Injection, Aricept® 5 mg film-coated tablet and Aricept® 10 mg film-coated tablet in people with Bioavailability Study on Healthy Volunteers, run by G2GBio, Inc. at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability Study on Healthy Volunteers
- What is being tested?
- GB-5001A 280 mg long acting Injection, Aricept® 5 mg film-coated tablet and Aricept® 10 mg film-coated tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Aug 2025to 15 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
- Healthy male subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during the screening and could be considered healthy based on the evaluation.
- Aged 19-45 years inclusive.
- Non-smokers.
- Body mass index within 18.5 to 30.0 kg/m2.
- Vital signs (after 10 minutes rest) must be within the range (i.e Systolic blood pressure 100 - 129 mmHg; Diastolic blood pressure 60 - 84 mmHg)
- Willing to practice abstention or non-hormonal contraception during the study.
Who cannot join
- History of allergy or hypersensitivity or contraindication to Donepezil or other allied drugs.
- Any major illness in the past 90 days or clinically significant ongoing chronic medical illness.
- Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal failure or renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc.
- Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
- Clinically significant hematology abnormalities.
- Clinically significant 12-Lead electrocardiogram (12-Lead ECG) abnormalities.
Show all 22Show fewer
- Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery.
- Past history of anaphylaxis or angioedema.
- History of drug or alcohol abuse within 12 months prior to screening for this study.
- Participation in any clinical trial within the past 90 days calculated from the last visit until this study's first dosing day.
- History of any bleeding or coagulative disorders.
- Presence of difficulty in accessibility of veins in left or right arm.
- A donation or significant blood loss within 90 days before this study's first dosing day.
- Intake of any prescription drug (especially Donepezil), non prescription drug (including hormonal contraception), food supplements or herbal medicines within 28 days of this study's first dosing day.
- History of allergic contact dermatitis.
- History of muscle weakness.
- History of myasthenia gravis.
- History of peptic ulcer or Gastritis.
- History of seizure.
- History of bronchitis, asthma, or lung infections.
- Bradycardia was detected during the screening process.
- Difficulty in swallowing capsule or tablet.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- GB-5001A 280 mg long acting Injection, Aricept® 5 mg film-coated tablet, Aricept® 10 mg film-coated tablet
- Keywords
- Donepezil, Aricept, Bioavailability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-5001A 280 mg long acting InjectionDrug
Depending on the cohort, doses will be varied to administer.
Aricept® 5 mg film-coated tabletDrug
Aricept® (donepezil hydrochloride) 5 mg film-coated tablet administered orally as an active comparator
Aricept® 10 mg film-coated tabletDrug
Aricept® (donepezil hydrochloride) 10 mg film-coated tablet administered orally as an active comparator
| Study group | Role | What they receive |
|---|---|---|
| GB-5001A | Experimental | GB-5001A 280 mg long acting Injection Receives: Drug: GB-5001A 280 mg long acting Injection |
| Aricept & GB-5001A | Experimental | Active Comparator: Aricept® 5 mg tablet and Experimental: GB 5001A 280 mg long acting Injection Receives: Drug: GB-5001A 280 mg long acting Injection; Drug: Aricept® 5 mg film-coated tablet |
| Aricept | Active comparator | Aricept® 5 mg tablet and Aricept® 10 mg tablet Receives: Drug: Aricept® 5 mg film-coated tablet; Drug: Aricept® 10 mg film-coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter
Peak plasma concentration during steady state (Cmax,ss)
Measured: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Minimum plasma concentration during steady state (Cmin,ss)
Measured: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Average drug concentration at steady state (Cav,ss)
Measured: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Time to maximum concentration at steady state (Tmax,ss)
Measured: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Area under the plasma concentration versus time curve during a dosage interval at steady state (AUCτ,ss)
Measured: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Area under the plasma concentration versus time curve extrapolated to infinite time (AUCinf)
Measured: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Apparent total body clearance of drug from plasma after oral administration at steady state (CLss/F)
Measured: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Apparent volume of distribution at steady state (Vss/F)
Measured: 204 days of G1, 226 days of G2, 40 days of G3
Pharmacokinetic parameter
Plasma half life (t1/2)
Measured: 204 days of G1, 226 days of G2, 40 days of G3
Secondary outcomes (1)
Adverse events
Number of subjects and Incidences with adverse events by Study arm.
Measured: Day 1 to Day 226
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start12 Aug 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability Study on Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- G2GBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT Equilab International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799090
- Sponsor's protocol ID
- GB5001A
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07799090
- Acronym / sponsor ID
- GB5001A
- Keywords
- Donepezil, Aricept, Bioavailability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- G2GBio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PT Equilab International
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GB-5001A | Experimental | Drug: GB-5001A 280 mg long acting InjectionGB-5001A 280 mg long acting Injection |
| Aricept & GB-5001A | Experimental | Drug: GB-5001A 280 mg long acting Injection, Drug: Aricept® 5 mg film-coated tabletActive Comparator: Aricept® 5 mg tablet and Experimental: GB 5001A 280 mg long acting Injection |
| Aricept | Active comparator | Drug: Aricept® 5 mg film-coated tablet, Drug: Aricept® 10 mg film-coated tabletAricept® 5 mg tablet and Aricept® 10 mg tablet |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
- Healthy male subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during the screening and could be considered healthy based on the evaluation.
- Aged 19-45 years inclusive.
- Non-smokers.
- Body mass index within 18.5 to 30.0 kg/m2.
Key exclusion criteria (22 listed)
- History of allergy or hypersensitivity or contraindication to Donepezil or other allied drugs.
- Any major illness in the past 90 days or clinically significant ongoing chronic medical illness.
- Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal failure or renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc.
- Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
- Clinically significant hematology abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB-5001A 280 mg long acting InjectionDepending on the cohort, doses will be varied to administer. | Drug | Aricept & GB-5001A, GB-5001A |
| Aricept® 5 mg film-coated tabletAricept® (donepezil hydrochloride) 5 mg film-coated tablet administered orally as an active comparator | Drug | Aricept, Aricept & GB-5001A |
| Aricept® 10 mg film-coated tabletAricept® (donepezil hydrochloride) 10 mg film-coated tablet administered orally as an active comparator | Drug | Aricept |
Primary outcome
Pharmacokinetic parameter
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Peak plasma concentration during steady state (Cmax,ss)
Pharmacokinetic parameter
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Minimum plasma concentration during steady state (Cmin,ss)
Pharmacokinetic parameter
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Average drug concentration at steady state (Cav,ss)
Pharmacokinetic parameter
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Time to maximum concentration at steady state (Tmax,ss)
Pharmacokinetic parameter
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Area under the plasma concentration versus time curve during a dosage interval at steady state (AUCτ,ss)
Pharmacokinetic parameter
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Area under the plasma concentration versus time curve extrapolated to infinite time (AUCinf)
Pharmacokinetic parameter
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Apparent total body clearance of drug from plasma after oral administration at steady state (CLss/F)
Pharmacokinetic parameter
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Apparent volume of distribution at steady state (Vss/F)
Pharmacokinetic parameter
Time frame: 204 days of G1, 226 days of G2, 40 days of G3
Plasma half life (t1/2)
1 secondary outcome
Adverse events
Time frame: Day 1 to Day 226
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Related trials for Bioavailability Study on Healthy Volunteers
RecruitingPhase 1
A Study to Assess the Relative Bioavailability of Irafamdastat (BMS-986368) and to Assess the Food Effect on the Pharmacokinetics of Irafamdastat in Healthy Adult Participants
Healthy Volunteers
RecruitingPhase 1
A Study to Investigate the Relative Bioavailability of 2 Tablet Formulations and the Effect of Food on the Pharmacokinetics of BGB-58067 in Healthy Participants
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants
Breast Cancer
RecruitingPhase 1
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
Healthy Volunteers
Not yet recruitingPhase 1
A Study to Learn About How Food Affects the Uptake of Study Medicine Prifetrastat Into the Blood in Healthy Adults
Healthy Adults
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB-5001A 280 mg long acting Injection, Aricept® 5 mg film-coated tablet and Aricept® 10 mg film-coated tablet in people with Bioavailability Study on Healthy Volunteers, run by G2GBio, Inc. at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter (time frame: 204 days of G1, 226 days of G2, 40 days of G3). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.