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COMPLETEDEARLY_PHASE1

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

NCT04462029•Boryung Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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 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.

Eligibility

Age

19 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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
+16 more criteria

Locations (1)

Inha University Hospital

Incheon, South Korea

Key Dates

Start Date

June 5, 2020

Primary Completion Date

October 7, 2020

Completion Date

October 7, 2020

Last Updated

October 28, 2020

Enrollment

ACTUAL participants

Conditions

Dementia Alzheimers

Interventions

BR4002

DRUG

BR4002-1

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Spanish-language Caregiver-Enabled Care Program

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