Search / Trial NCT06226727

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

Launched by BORYUNG PHARMACEUTICAL CO., LTD · Jan 18, 2024

Trial Information

Current as of October 08, 2024

Completed

Keywords

Description

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * 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.
  • Exclusion Criteria:
  • * 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 have a medical history of gastrectomy(Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
  • * 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.
  • * In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.

About Boryung Pharmaceutical Co., Ltd

Boryung Pharmaceutical Co., Ltd. is a leading South Korean biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapeutic solutions. Established with a commitment to advancing healthcare, Boryung focuses on various therapeutic areas, including oncology, cardiology, and infectious diseases. The company leverages cutting-edge technologies and robust clinical trial methodologies to bring new medications to market, enhancing patient outcomes globally. With a strong emphasis on quality and compliance, Boryung Pharmaceutical continues to expand its footprint in the global pharmaceutical landscape through strategic collaborations and a dedication to scientific excellence.

Locations

Seoul, Gwanakgu, Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0