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A Study to Compare the Pharmacokinetics of BR4002 and BR4002-1 in Healthy Volunteers
A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability of BR4002 Comparing to BR4002-1 in Healthy Volunteers
Lead sponsor
Assets
BR4002 / BR4002-1
Listed sites
1
Recruiting sites
-
Enrollment
18
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Age 19-55
Primary endpoints
•Pharmacokinetic variables -AUC from time 0 to t after single dosing(AUCt)•Pharmacokinetic variables - Cmax of BR4002 and BR4002-1
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Healthy adults aged ≥ 19 and ≤ 55 years at screening
2. Body weight of ≥ 50 kg with calculated body mass index (BMI) of ≥ 18.0 to ≤ 29.0 kg/m2
3. Determined eligible based on the results of physical examination and investigator questioning conducted according to this protocol. That is, absence of congenital or chronic disease, and absence of pathological symptoms or findings based on medical examination in the last 3 years.
4. Determined eligible based on the results of the laboratory tests and electrocardiogram (ECG) conducted according to this protocol
5. Voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a detailed explanation on this study and fully understanding the information
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:
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
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
4 endpointsPharmacokinetic variables -Area Under the concentration-time Curve from time 0 to t after single dosing(AUCt) of BR4002 and BR4002-1
Time frame:0~240 hours after medication
concentration, descriptive
Pharmacokinetic variables - maximum observed plasma concentration(Cmax) of BR4002 and BR4002-1
Time frame:0~240 hours after medication
concentration, descriptive
Pharmacokinetic variables - Area Under the concentration-time Curve from time 0 to infinite after single dosing(AUCinf) of BR4002 and BR4002-1
Time frame:0~240 hours after medication
concentration, descriptive
Pharmacokinetic variables - Time of occurrence of Cmax(Tmax) of BR4002 and BR4002-1
Time frame:0~240 hours after medication
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.