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NCT06889064CompletedPhase 1

A Study to Evaluate the Pharmacokinetic, Pharmacodynamic Characteristics and the Safety After Administration by Doses of BR1400-1, BR1400-2, BR1400-3 in Healthy Adult Volunteers

A Randomized, Open-label, Single Oral Dose, Three-arm, Parallel Design, Phase 1 Study to Evaluate the Pharmacokinetic, Pharmacodynamic Characteristics and the Safety After Administration by Doses of BR1400-1, BR1400-2, BR1400-3 in Healthy Volunteers

Source: ClinicalTrials.gov · Last updated 21 Mar 2025

Brief summary (registry, in English)

The purpose of this clinical study is to evaluate the pharmacokinetic, pharmacodynamic characteristics and the safety after administration by doses of "BR1400-1", "BR1400-2", "BR1400-3" in healthy volunteers

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
28 (actual)
First submitted
17 Mar 2025
Start date
24 Sept 2024
Primary completion date
8 Oct 2024
Lead sponsor
Boryung Pharmaceutical Co., Ltd
NCT number
NCT06889064

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 28
  • From 24 Sept 2024 to the primary completion date, 8 Oct 2024
  • 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, not your situation.

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 prior to the first day of administration or have taken ethical drugs, over the counter drugs, herbal medicines, health functional foods 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 bioequivalence tests or other clinical trials 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 diseases (ex. crohn's disease, ulcerative colitis, etc.) or gastrointestinal resection (Except for simple appendectomy, hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases

Other

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

Who the study is looking for

  • Those who have body mass index (BMI) of 18.0kg/m2 to 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 agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\* from the date of consent to 7 days after the last administration and disagree to provide their sperm or ovum.
    • Methods of contraception accepted in clinical trial: Combined use of non hormonal 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.
  • Those who spontaneously decide to participate and sign written consent to observe the subject's compliance during this clinical trial 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.

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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Seoul Bumin Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

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