A Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1018-1 and BR1018-2 in Healthy Adult Subjects

  • STATUS
    Recruiting
  • days left to enroll
    85
  • participants needed
    36
  • sponsor
    Boryung Pharmaceutical Co., Ltd
Updated on 4 October 2022
electrocardiogram
body mass index
Accepts healthy volunteers

Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and compare the safety and tolerability after repeated separate or combined administrations of BR1018-1 and BR1018-2 in healthy adults.

Description

A total of 36 subjects will be randomized into 6 sequence groups, 6 subjects per sequence group. The Investigational Products wil be according to the treatment group (A,B,C) assigned to each sequence group in Period 1, Period 2 and Period 3.

Details
Condition Hypertension, Hyperlipidemia (E.G., Hypercholesterolemia)
Treatment BR1018-1, BR1018-2
Clinical Study IdentifierNCT05460364
SponsorBoryung Pharmaceutical Co., Ltd
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy adults aged 19 to 55 years at screening
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
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
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)
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

Those who have clinically significant diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric disorders, or urinary system, as well as drug abuse, or a history thereof
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
Those who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc
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
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
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
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
Those who continue to smoke (>10 cigarettes/day), or who are unable stop smoking during hospitalization within the clinical study period
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
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
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.)
Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbiturates, within 30 days prior to the study initiation
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
Pregnant women, potentially pregnant women, or breast-feeding women
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
Those who are unwilling or unable to comply with the dietary and lifestyle guidelines
required for the clinical study
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.)
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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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