A Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1018-1 and BR1018-2 in Healthy Adult Subjects
NCT ID: NCT05460364
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2022-08-04
2022-10-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1018 and Coadministration of BR1018A and BR1018B in Healthy Adult Volunteers
NCT06889012
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C714 and C714R in Healthy Adults
NCT06933459
To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers
NCT05463497
Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects
NCT03123185
The Effect of Multiple Oral Doses of BI 1356 BS on Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of Simvastatin and on the Pharmacokinetics of Its Metabolite Simvastatin Acid in Healthy Male Volunteers
NCT02183623
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sequence 1
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.
\*sequence 1: A-B-C
BR1018-1
Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
BR1018-2
Treatment group B : One tablet of BR1018-2 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
Sequence 2
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.
\*sequence 2: A-C-B
BR1018-1
Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
BR1018-2
Treatment group B : One tablet of BR1018-2 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
Sequence 3
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.
\*sequence 3: B-A-C
BR1018-1
Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
BR1018-2
Treatment group B : One tablet of BR1018-2 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
Sequence 4
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.
\*sequence 4: B-C-A
BR1018-1
Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
BR1018-2
Treatment group B : One tablet of BR1018-2 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
Sequence 5
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.
\*sequence 5: C-A-B
BR1018-1
Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
BR1018-2
Treatment group B : One tablet of BR1018-2 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
Sequence 6
The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.
\*sequence 6: C-B-A
BR1018-1
Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
BR1018-2
Treatment group B : One tablet of BR1018-2 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BR1018-1
Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
BR1018-2
Treatment group B : One tablet of BR1018-2 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Those who weigh at least 50 kg at the time of screening and have a calculated body mass index (BMI) within the range of 18.0 to 30.0 kg/m2
3. Those who have been determined to be eligible as subjects through physical examinations and interviews conducted in accordance with this protocol. In other words, those who have no congenital or chronic diseases and have no abnormal symptoms or findings based on medical examination results within the last 3 years
4. Those who have been determined to be eligible as subjects as a result of clinical laboratory tests and electrocardiography performed according to this protocol (if the results are within the reference values of Inha University Hospital or if the investigator determines that the clinical laboratory test and electrocardiography results are not clinically significant even if they are out of range)
5. Those who voluntarily decide to participate in the study and provide written consent to follow the study directions after listening to and fully understanding the detailed explanation on this study
Exclusion Criteria
2. Those who have hypersensitivity reactions to drugs containing fimasartan, amlodipine, ezetimibe, atorvastatin, or same-class ingredients, yellow no. 5 (sunset yellow FCF), dihydropyridine derivatives, or to other drugs (aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivity reactions thereto.
3. Those who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
4. Those who have a history of gastrointestinal diseases (e.g., Crohn's disease, ulcerative disease, etc.) or gastrointestinal surgery (however, simple appendectomy or hernia repair are excluded) that may affect the absorption of drugs
5. Those who have clinically significant hypotension (systolic blood pressure ≤ 90 mmHg) or hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg) at screening
6. Those who show any of the following results in the screening tests
* AST or ALT \> 2 times the upper limit of the normal range
* Total bilirubin \> 2.0 mg/dL
* CK \> 2 times the upper limit of the normal range
* Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2
7. Those who continue to drink alcohol (\>21 units/week; 1 unit = 10 g = 12.5 mL of pure alcohol), or who are unable to abstain from drinking during the clinical study period
8. Those who continue to smoke (\>10 cigarettes/day), or who are unable stop smoking during hospitalization within the clinical study period
9. Those who have participated in another clinical study or bioequivalence test (the last day of administration of the investigational product or bioequivalence test drug) within 6 months prior to the first administration date
10. Those who have donated whole blood within 60 days prior to the first day of administration or donated blood components within 30 days prior to the first day of administration or who have received a blood transfusion within 30 days
11. Those who took any prescription drugs or herbal medicines within 14 days prior to the first day of administration or any over-the-counter (OTC) drugs within 7 days prior to the first day of administration (however, if other conditions are appropriate according to the judgment of the investigator, they may participate in the clinical study.)
12. Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbiturates, within 30 days prior to the study initiation
13. Those who have been on a diet (especially grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first day of administration
14. Pregnant women, potentially pregnant women, or breast-feeding women
15. Those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically acceptable methods of contraception\* throughout the entire period from the date of the first administration of the investigational product to the end of the clinical study
* Medically acceptable methods of contraception: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used
16. Those who are unwilling or unable to comply with the dietary and lifestyle guidelines required for the clinical study
17. Those who have clinically significant abnormalities in the results of other clinical laboratory tests or who have been determined by the investigator to be ineligible to participate in the clinical study due to other reasons (e.g., non-compliance with instructions, uncooperative attitude, etc.)
19 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Inha University Hospital
Incheon, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BR-FAEAC-CT-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.