| Eligibility |
Inclusion Criteria:
1. Healthy adult volunteers aged between 19 and 55 at the time of screening
2. For men, those who weigh 50 kilograms or more and for women, those who weigh 45
kilograms or more and have a body mass index (BMI) between 18.0 and 30.0
3. Those who do not have any congenital or chronic disease and had no pathological
symptoms or findings in a medical examination
4. Those who are deemed suitable as subjects by the investigator within four weeks prior
to the first administration date of the investigational product based on the
characteristics of the drug as a result of interview, physical examination, clinical
laboratory test, and electrocardiogram
5. Those who are able to understand and follow instructions and participate throughout
the entire clinical trial period
6. Those who agree to contraception use during the clinical trial period and can comply
with medically accepted contraceptive methods (including those who are medically
infertile)
7. Those who have heard and fully understood a detailed description of this clinical
trial and have voluntarily decided to participate in the trial and have agreed in
writing to comply with the precautions
Exclusion Criteria:
1. Medical History
1. Those with or with a history of clinically significant diseases of the biliary
system (biliary obstructive disease, etc.), renal system (severe renal failure,
etc.), blood/oncology, cardiovascular system (congestive heart failure, coronary
or aortic/mitral stenosis or complications thereof, arrhythmia, renovascular
hypertension, etc.), respiratory system (asthma, chronic obstructive pulmonary
disease, etc.), liver (moderate or severe liver failure, etc.), endocrine system
(diabetes or impaired glucose tolerance, hypothyroidism, primary aldosteronism,
etc.), digestive system, musculoskeletal system, or central nervous system
disease (Parkinson's disease, etc.), or mental illness or malignant tumor
2. Those with a history of gastrointestinal disease (Crohn's disease, ulcers,
gastritis, gastrospasms, gastroesophageal reflux, acute or chronic pancreatitis,
etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery)
that may affect drug absorption
3. Those with a history of hypersensitivity or clinically significant
hypersensitivity to donepezil or drugs containing NAC or similar agents
(piperidine derivatives, etc.), or other drugs (aspirin, antibiotics, etc.)
4. Those who have suffered from a clinically significant disease within 30 days
before the first administration of the investigational product
2. Clinical Laboratory Tests
1. Those with systolic blood pressure = 140 mmHg or = 99 mmHg, or diastolic blood
pressure = 91 mmHg or = 59 mmHg, or measured pulse rate = 101 or = 40 times per
minute for vital signs measured in a sitting position after sufficient rest
2. Those who are tested positive for serological tests (hepatitis B, hepatitis C,
syphilis, HIV)
3. Patients with active liver disease, including a persistent increase of liver
enzyme levels (AST, ALT) of unknown etiology or an increase of liver enzyme
levels = 1.5 times the ULN
4. Patients with renal impairment of moderate or higher renal failure (GFR <60
mL/min based on the Cockcroft-Gault method)
5. Patients with CPK values increased by more than five times the ULN
6. In the case of clinically significant findings on an electrocardiogram or related
physical abnormalities or symptoms
7. If the investigator determines that it is difficult to proceed with the trial due
to results of physical examinations
3. Allergies and Drug Abuse
1. Those with genetic problems such as intolerance to the additivies for donepezil
or NAC
2. Those with a history of drug abuse or who tested positive for drug abuse in the
drug screening test
3. Those with genetic problems such as galactose intolerance, Lapp lactase
deficiency or glucose-galactose malabsorption
4. Contraindicated Concomitant Drugs/Diet
1. Those who have participated in other clinical trials within 180 days before the
first administration of the investigational product
2. Those who have taken metabolism-inducing or inhibiting drugs (CYP2D6 or CYP3A4
inducers, inhibitors, etc.) within 28 days before the first administration of the
investigational product
3. Those who have taken herbal medicine within 28 days, prescription drugs within 14
days, or over-the-counter drugs within seven days before the first administration
of the investigational product (however, if other conditions are reasonable, at
the discretion of the investigator, the subject may participate in the clinical
trial)
5. Other
1. Those who have done whole blood donation within 60 days, or apheresis within 28
days before the first administration of the investigational product, or received
a blood transfusion within 28 days before the first administration
2. Those who have consumed excessive alcohol within 28 days before the first
administration (alcohol > 30 g/day; soju > 150 cc/day (based on 20%), beer > 750
cc/day (based on 4%), liquor > 75 cc/day (based on 40%) , wine > 300 cc/day
(based on 10%))
3. Those who have smoked excessively within 28 days before the first administration
(cigarettes > 10 cigarettes/day) or those who could not quit smoking during the
clinical trial
4. Those who have consumed excessive caffeine within 28 days before the first
administration (coffee > 5 cups/day, tea > 1250 cc/day, coke 1250 cc/day)
5. Those who consume alcohol continuously or are unable to abstain from alcohol
during the clinical trial
6. Those who are judged unsuitable for participation in the clinical trial by the
investigator (study doctor) for other reasons, including the results of clinical
laboratory tests
|
