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Completed

NCT Number: NCT05875259

A Clinical Trial Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

The purpose of this study is to evaluate the pharmacokinetic interaction and safety between BR1019-1 and BR1019-2 in healthy adult subjects.

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inha University Hospital

Incheon, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults aged 19 to 55 years at screening
  • 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 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.)

Treatment and study plan

BR1019-1

Drug

Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.

BR1019-2

Drug

Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.

BR1019-1 + BR1019-2

Drug

Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.

Primary outcomes

  1. AUC0-24,ss

    Time frame: 0-48 hours after administration

    Area under the concentration-time curve from 0 h to 24 h of BR1019-1 and BR1019-2 at steady-state

  2. Cmax,ss

    Time frame: 0-48 hours after administration

    Maximum concentration of drug in plasma of BR1019-1 and BR1019-2 at steady-state

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple-dose, 6-sequence, 3-treatment, 3-period, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 25, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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