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NCT06226727CompletedPhase 1

A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2"

A Randomized, Open-label, Single Dose, Two-way Replicate Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2" in Healthy Volunteers

Source: ClinicalTrials.gov · Last updated 2 Apr 2024

Brief summary (registry, in English)

The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-1" and "BR1019-2" in healthy volunteers

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
52 (actual)
First submitted
18 Jan 2024
Start date
14 Feb 2024
Primary completion date
31 Mar 2024
Lead sponsor
Boryung Pharmaceutical Co., Ltd
NCT number
NCT06226727

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 52
  • From 14 Feb 2024 to the primary completion date, 31 Mar 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 ETC, OTC, Oriental medicine, Health functional food concerned about affecting this clinical trial within 10 days prior to the first day of administration. (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 administered their investigational products within 6 months prior to 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 its products, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.

Other illness

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

Other

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

Who the study is looking for

  • Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit
    • In case of a male subject, Those who weigh 50 kg or more
    • In case of a female subject, Those who weigh 45 kg or more
  • Those who decide to voluntarily participate after listening to and understanding the detailed explanation of this clinical trial and who sign a written consent to comply with the subject's precautions during this clinical trial.

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
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.