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

  • STATUS
    Recruiting
  • participants needed
    18
  • sponsor
    Boryung Pharmaceutical Co., Ltd
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Updated on 16 February 2024
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body mass index
chronic disease
electrocardiogram
electrocardiogram (ecg)

Summary

This study is designed as a randomized, open-label, single-dose, 6x3 crossover study.

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 Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.

Details
Condition Alzheimer's Disease, Alzheimer's Disease
Age 19years - 55years
Treatment BR4002, BR4002-1
Clinical Study IdentifierNCT04462029
SponsorBoryung Pharmaceutical Co., Ltd
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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