A Study to Compare the Pharmacokinetics of BR4002 and BR4002-1 in Healthy Volunteers

Exclusion Criteria

• •1. Hypersensitivity to, or history of clinically significant hypersensitivity to donepezil hydrochloride, piperidine derivatives or any ingredients of piperidine derivatives, or other drugs (aspirin, antibiotics, etc.)
• •2. Hereditary disorders including galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption
• •3. History of heart disease such as sinus node syndrome, intra-atrial conduction disturbance or atrioventricular junctional conduction disturbance
• •4. Ongoing administration of non-steroidal anti-inflammatory drugs or history of peptic ulcer
• •5. History of asthma or obstructive pulmonary disease
• •6. Extrapyramidal disorder
• •7. Psychotic disorders or drug addiction
• •8. Presence or prior history of a gastrointestinal disorder or prior history of gastrointestinal surgery or skin graft that may affect the absorption of the IP
• •9. Presence or prior history of clinically significant cardiovascular, respiratory, hepatic, renal, neurological, endocrine, hematological and oncological, psychotic, or urinary disease
• •10. Clinically significant hypotension (systolic blood pressure \< 90 mmHg) or hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg) at screening
• •11. Any of the following results from screening tests:
• •* AST or ALT \> 2 times the upper limit of normal
• •* Total bilirubin \> 2.0 mg/dL
• •* Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2
• •12. QTc \> 450 ms or any clinically significant abnormal finding from an ECG result at screening
• •13. Continuous alcohol intake or inability to stop drinking during the study period
• •14. Continuous smoking or inability to stop smoking throughout the hospitalization during the study period
• •15. Participated in another clinical study or bioequivalence study within 6 months prior to the first administration of the IP
• •16. Donated whole blood within 60 days or blood components within 30 days, or received blood transfusion within 30 days prior to the first administration of the IP
• •17. Used any prescription drugs or herbal medicines within 14 days, or any over-the-counter (OTC) drugs within 7 days prior to the first administration of the IP
• •18. Used drugs inducing and inhibiting drug-metabolizing enzymes, such as barbitals, within 1 month prior to initiation of the study
• •19. Have been on a diet (especially grapefruit juice or its product) which may affect absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first administration of the IP
• •20. Do not agree to exclude the possibility of pregnancy by using medically acceptable methods of contraception from the first day of administration of the IP up to 7 days after the last day of administration of the IP
• •21. Unwillingness or inability to comply with the diet and lifestyle guidelines required for the study
• •22. Clinically significant abnormal laboratory results or considered ineligible for study participation by the investigator for any other reason
• •23. Women who are pregnant, have a positive serum/urine hCG test, or are breastfeeding