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NCT Number: NCT06867497

A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1

The purpose of this clinical study is to compare and evaluate the pharmacokinetic characteristics and the safety between administration of BR2021 and BR2021-1 in patients with metastatic adenocarcinoma of the pancreas

Recruiting

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Key information

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those with histologically or cytologically proven metastatic adenocarcinoma of the pancreas
  • Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically recognized methods of contraception (contraceptives administration & transplantation or intrauterine device(IUD), sterilization(vasectomy, tubal ligation, etc.), barrier methods (spermicide & male condom, combined use of contraceptive diaphragm, sponge or cervical cap)) from the date of the first administration of the investigational products to at least 6 months after the last administration date and disagree to provide their sperm or ovum.
  • Those who spontaneously decide to participate and sign written consent to comply with the subject's precautions after listening to and fully understanding detailed explanation of this clinical trial

Exclusion criteria

  • In the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.
  • Those who have to administer this study's contraindicated drugs with the investigational product from 2 weeks before the participation until end of this study
  • 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 from 48 hours before the first administration date to post study visit(PSV)
  • Those who can't discontinue other drugs except the investigational product of this study that may affect the metabolism and excretion of the drug for the entire study period (However, if necessary, such as treatment of adverse event, it can be administrated according to investigator's judgment)
  • Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 4 weeks 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) or those whose last administration date of their investigational products of other clinical trials doesn't elapse five times the half-life of their investigational products based on the first administration date of investigational product of this study

Treatment and study plan

BR2021

Drug

intravenous administration for 30 minutes

BR2021-1

Drug

intravenous administration for 30 minutes

Primary outcomes

  1. AUCt

    Time frame: 0~72 hours after administration

    Area under the Plasma Concentration-Time Curve from 0 to time t

  2. Cmax

    Time frame: 0~72 hours after administration

    Maximum Concentration of Drug in Plasma

Study contacts

Contact information is provided by the study sponsor or research team.

Shin-young Oh

CONTACT

[email protected]

+82-2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Multi-center, Open-label, Randomized, Two-stage, Two-way Crossover Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1 in Patients With Metastatic Adenocarcinoma of the Pancreas

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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