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

Last updated: April 8, 2025
Sponsor: Boryung Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Adenocarcinoma

Treatment

BR2021

BR2021-1

Clinical Study ID

NCT06867497
BR-ABX-CT-101
  • Ages 19-74
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Those with histologically or cytologically proven metastatic adenocarcinoma of thepancreas

  • Those who agree to rule out the possibility of their and their spouses' or sexualpartners' pregnancy by using medically recognized methods of contraception (contraceptives administration & transplantation or intrauterine device(IUD),sterilization(vasectomy, tubal ligation, etc.), barrier methods (spermicide & malecondom, combined use of contraceptive diaphragm, sponge or cervical cap)) from thedate of the first administration of the investigational products to at least 6months after the last administration date and disagree to provide their sperm orovum.

  • Those who spontaneously decide to participate and sign written consent to complywith the subject's precautions after listening to and fully understanding detailedexplanation of this clinical trial

Exclusion

Exclusion Criteria:

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

  • Those who have to administer this study's contraindicated drugs with theinvestigational product from 2 weeks before the participation until end of thisstudy

  • Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or foodcontaining grapefruit, etc.) that may affect the absorption, distribution,metabolism, and excretion of the drug from 48 hours before the first administrationdate to post study visit(PSV)

  • Those who can't discontinue other drugs except the investigational product of thisstudy that may affect the metabolism and excretion of the drug for the entire studyperiod (However, if necessary, such as treatment of adverse event, it can beadministrated 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 firstadministration date (However, the termination for participation in other clinicaltrials are based on the last administration date of their investigational products)or those whose last administration date of their investigational products of otherclinical trials doesn't elapse five times the half-life of their investigationalproducts based on the first administration date of investigational product of thisstudy

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: BR2021
Phase: 1
Study Start date:
February 24, 2025
Estimated Completion Date:
October 28, 2025

Connect with a study center

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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