Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics From Single Dose of Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers

Age

19–55

Sex

MALE

Healthy volunteers

Accepted

You may be eligible if

Healthy adult males,19 to 55 years of age, inclusive at the time of screening visit
Subject with a body weight of 55 kg or more and a body mass index (BMI) equal to or greater than 18.5 kg/m² but less than 30 kg/m²
Subject without congenital or chronic conditions, and with no pathological symptoms or findings on internal medical examination
Subject who has been deemed suitable based on screening test results assessed by the principal investigator
Subject who can understand this clinical trial, provide informed written consent prior to the clinical trial procedures

You may not be if

Subjects with the following medical history or symptoms, as determined by the Principal Investigator to pose a risk to the trial.
* Renal/Genitourinary, Gastrointestinal, Cardiovascular, Cerebrovascular, Pulmonary, Endocrine, Immune, Musculoskeletal, Neurological, Psychiatric, Dermatological, and Hematological conditions.
* Rhabdomyolysis
* Seizure, Epilepsy, Fainting
* peptic ulcer or gastrointestinal hemorrhage
* Gastrointestinal pathology, uncontrollable gastrointestinal symptoms or a history of disturbing absorption, distribution, metabolism or excretion
* Severe physical/organ abnormalities
* Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus
Subjects with a history of, or currently receiving, the following medications, as determined by the Principal Investigator regarded as a risk to the trial.
* Medications, including antidepressants, that can induce Rhabdomyolysis
* Medications with a risk of ulcer development.
* Potent inhibitors of cytochrome P450 (CYP) enzymes
* Anticholinergic drugs, cholinomimetics, and other cholinesterase inhibitors
Subjects who have difficulty with venipuncture or injection procedures via catheter or intravenous access
Subjects who have been consistently engaging in excessive smoking or consuming caffeine or alcohol within the last 3 months prior to screening, or Subjects who cannot abstain from smoking, caffeine, and alcohol consumption for at least 2 days before the scheduled administration of the investigational product or during the inpatient period

Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics From Single Dose of Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers

What this study is about

Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics From Single Dose of Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers

What this study is about