Status:
COMPLETED
A Study to Compare the Pharmacokinetics of BR4002 and BR4002-1 in Healthy Volunteers
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Dementia Alzheimers
Eligibility:
All Genders
19-55 years
Phase:
EARLY_PHASE1
Brief Summary
This study is designed as a randomized, open-label, single-dose, 6x3 crossover study.
Detailed Description
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in...
Eligibility Criteria
Inclusion
- Healthy adults aged ≥ 19 and ≤ 55 years at screening
- Body weight of ≥ 50 kg with calculated body mass index (BMI) of ≥ 18.0 to ≤ 29.0 kg/m2
- 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.
- Determined eligible based on the results of the laboratory tests and electrocardiogram (ECG) conducted according to this protocol
- 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
- 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.)
- Hereditary disorders including galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption
- History of heart disease such as sinus node syndrome, intra-atrial conduction disturbance or atrioventricular junctional conduction disturbance
- Ongoing administration of non-steroidal anti-inflammatory drugs or history of peptic ulcer
- History of asthma or obstructive pulmonary disease
- Extrapyramidal disorder
- Psychotic disorders or drug addiction
- 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
- Presence or prior history of clinically significant cardiovascular, respiratory, hepatic, renal, neurological, endocrine, hematological and oncological, psychotic, or urinary disease
- Clinically significant hypotension (systolic blood pressure \< 90 mmHg) or hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg) at screening
- 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
- QTc \> 450 ms or any clinically significant abnormal finding from an ECG result at screening
- Continuous alcohol intake or inability to stop drinking during the study period
- Continuous smoking or inability to stop smoking throughout the hospitalization during the study period
- Participated in another clinical study or bioequivalence study within 6 months prior to the first administration of the IP
- 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
- 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
- Used drugs inducing and inhibiting drug-metabolizing enzymes, such as barbitals, within 1 month prior to initiation of the study
- 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
- 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
- Unwillingness or inability to comply with the diet and lifestyle guidelines required for the study
- Clinically significant abnormal laboratory results or considered ineligible for study participation by the investigator for any other reason
- Women who are pregnant, have a positive serum/urine hCG test, or are breastfeeding
Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04462029
Start Date
June 5 2020
End Date
October 7 2020
Last Update
October 28 2020
Active Locations (1)
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1
Inha University Hospital
Incheon, South Korea