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NCT06889012CompletedPhase 1

A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1018 and Coadministration of BR1018A and BR1018B in Healthy Adult Volunteers

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 4-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1018" and Coadministration of "BR1018A" and "BR1018B" in Healthy Volunteers

Source: ClinicalTrials.gov · Last updated 12 Sept 2025

Brief summary (registry, in English)

The purpose of this clinical study is to evaluate the pharmacokinetics and the safety after administration of BR1018 and coadministration of BR1018A and BR1018B in healthy volunteers

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
60 (actual)
First submitted
17 Mar 2025
Start date
7 May 2025
Primary completion date
23 Jul 2025
Lead sponsor
Boryung Pharmaceutical Co., Ltd
NCT number
NCT06889012

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 60
  • From 7 May 2025 to the primary completion date, 23 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days before the first administration date or have taken drugs concerned about affecting this clinical trial within 10 days before the first administration date. (However, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
  • Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first administration date. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
  • Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours before the first administration date

Other illness

  • Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)

Other

  • In the case of a female subject, those suspected pregnancy or pregnant woman or lactating woman.

Who the study is looking for

  • Those who have body mass index (BMI) of more than 18.0kg/m2 and less than 30.0kg/m2 at screening visit.
    • For men, Those who weigh 50 kg or more
    • For women, Those who weigh 45 kg or more
  • Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
  • Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(Except for hormone drugs) from the date of consent to 14 days after the last administration and disagree to provide their sperm or ovum.
    • Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.

Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Clinical Research Center, H PLUS Yangji Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.