Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04462029
Other study ID # BR-DPZ-CT-102
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 5, 2020
Est. completion date October 7, 2020

Study information

Verified date October 2020
Source Boryung Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date October 7, 2020
Est. primary completion date October 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BR4002
Administration to the T1 group: 5 mg of BR4002 (patch) will be attached using an applicator for 24 hours Administration to the T2 group: 5 mg of BR4002 (patch) will be attached without using an applicator for 24 hours
BR4002-1
Administration to the R group: 5 mg of BR4002-1 (oral formulation) will be administered with 150 mL of water

Locations

Country Name City State
Korea, Republic of Inha University Hospital Incheon

Sponsors (1)

Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic variables -Area Under the concentration-time Curve from time 0 to t after single dosing(AUCt) of BR4002 and BR4002-1 PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed. 0~240 hours after medication
Primary Pharmacokinetic variables - maximum observed plasma concentration(Cmax) of BR4002 and BR4002-1 PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed. 0~240 hours after medication
Secondary Pharmacokinetic variables - Area Under the concentration-time Curve from time 0 to infinite after single dosing(AUCinf) of BR4002 and BR4002-1 PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed. 0~240 hours after medication
Secondary Pharmacokinetic variables - Time of occurrence of Cmax(Tmax) of BR4002 and BR4002-1 PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed. 0~240 hours after medication
See also
  Status Clinical Trial Phase
Recruiting NCT05328115 - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease Phase 1
Completed NCT03378245 - Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations N/A
Recruiting NCT04871698 - On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs
Active, not recruiting NCT05847153 - MASC: Reducing Stress for Caregivers N/A
Recruiting NCT04863859 - Persons With Dementia and Their Extended Family Caregivers
Active, not recruiting NCT05529277 - Implementing Dementia Care Management Into Routine Care in the Region Siegen-Wittgenstein
Active, not recruiting NCT03631069 - Detecting Dementia in the Retina Using Optical Coherence Tomography
Not yet recruiting NCT06047340 - Feasibility Study of Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease N/A
Terminated NCT03682874 - Identifying Novel Aging Targets for Treatment of Delirium
Completed NCT03907748 - Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia N/A
Completed NCT04058886 - Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers N/A
Not yet recruiting NCT05606445 - Surface EMG to Measure Paratonia in Dementia
Recruiting NCT04308512 - Care Coordination System for People With Dementia Phase 1/Phase 2
Active, not recruiting NCT03943641 - Dementia Risk Prediction Model: Development and Validation
Not yet recruiting NCT05245903 - Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside
Not yet recruiting NCT06396377 - Interest of the Reborn® Doll as a TO in the Care of Residents With Alzheimer's Disease or a Related Disorder N/A
Recruiting NCT03472482 - Optical Coherence Tomography in Cerebral Amyloidosis
Recruiting NCT04313582 - Feasibility of the SmartPrompt for Improving Everyday Function in Dementia N/A
Recruiting NCT05315895 - The Dampness Syndrome of Chinese Medicine Cohort Study
Completed NCT04428112 - Rural Dementia Caregiver Project N/A