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Search / Trial NCT07083388

A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fasting)

Launched by BORYUNG PHARMACEUTICAL CO., LTD · Jul 16, 2025

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Dapagliflozin Pioglitazone Metformin H Cl

ClinConnect Summary

This clinical trial is studying how the body processes and responds to a new diabetes-related medicine called "BR3006" compared to taking three related components ("BR3006A," "BR3006B," and "BR3006C") together. The goal is to understand the safety and how these medicines are absorbed and used by the body in healthy adults who have not eaten before taking the medicine. This helps researchers learn if the new medicine works well and is safe before testing it in people with diabetes.

Adults over 19 years old who are generally healthy and pass certain lab tests may be eligible to join the study. Participants must not have taken any other experimental medicines recently, should not have certain gut-related surgeries or diseases, and cannot be pregnant or nursing. If you join, you will take the medicine once while fasting and have some tests to check how your body handles it and to monitor your safety. The study is currently looking for volunteers and includes both men and women.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults aged over 19 at the time of consent
  • Those who are eligible to participate in the clinical trial at the discretion of the principal investigator (or a subinvestigator) through laboratory tests such as hematology tests, blood chemistry tests, serology tests, urine tests, and electrocardiogram (ECG) tests that were planned/performed with specification to the investigational product.
  • Those who provided written consent after receiving sufficient explanations and fully understood the objective and details of this clinical trial, the characteristics of the investigational product, and the expected adverse events.
  • Exclusion Criteria:
  • Those who have administered investigational products within 6 months from the first dose administration date in another clinical trial (including bioequivalent studies) (The end of study date is based on the last dose administration date.)
  • Those who have undergone gastrointestinal surgeries or have gastrointestinal diseases (except appendectomy or hernia surgery) that may affect the absorption of the investigational products
  • Those who are pregnant, suspected of pregnancy, or nursing

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, Gwanak Gu, Korea, Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported