Bioavailability Study on Healthy Volunteers
Conditions
Keywords
Donepezil, Aricept, Bioavailability, Pharmacokinetics
Brief 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.
Interventions
DRUGGB-5001A 280 mg long acting Injection
Depending on the cohort, doses will be varied to administer.
DRUGAricept® 5 mg film-coated tablet
Aricept® (donepezil hydrochloride) 5 mg film-coated tablet administered orally as an active comparator
DRUGAricept® 10 mg film-coated tablet
Aricept® (donepezil hydrochloride) 10 mg film-coated tablet administered orally as an active comparator
Sponsors
G2GBio, Inc.
PT Equilab International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter | 204 days of G1, 226 days of G2, 40 days of G3 | Peak plasma concentration during steady state (Cmax,ss) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Day 1 to Day 226 | Number of subjects and Incidences with adverse events by Study arm. |
Countries
Indonesia
Outcome results
None listed