Fact CheckerSign in

NCT06289920CompletedPhase 1

A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fasting Conditions in Healthy Adult Volunteers

An Open Label, Randomized, Fasting, Single Dose, 2-sequence, 2-period, Crossover Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" in Healthy Adult Volunteers

Source: ClinicalTrials.gov · Last updated 24 May 2024

Brief summary (registry, in English)

The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult volunteers

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
47 (actual)
First submitted
26 Feb 2024
Start date
2 Mar 2024
Primary completion date
28 Mar 2024
Lead sponsor
Boryung Pharmaceutical Co., Ltd
NCT number
NCT06289920

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 47
  • From 2 Mar 2024 to the primary completion date, 28 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 drugs 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 other clinical trials(including bioequivalence tests) and 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)

Other illness

  • Those who have a medical history of gastrointestinal surgery 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, 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 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.

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.