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Recruiting NCT06867497

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

Phase I Interventional Metastatic Adenocarcinoma of the Pancreas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BR2021, BR2021-1.
Who it may be relevant to
Registry conditions: Metastatic Adenocarcinoma of the Pancreas. Basic parameters: 19 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug BR2021
    intravenous administration for 30 minutes
  • Drug BR2021-1
    intravenous administration for 30 minutes

Primary outcome measures

  • AUCt [Time frame: 0~72 hours after administration]
  • Cmax [Time frame: 0~72 hours after administration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 2 centers
  • Asan Medical Center — Seoul
  • The Catholic University of Korea Seoul St. Mary's Hospital — Seoul

Identifiers

NCT: NCT06867497 · BR-ABX-CT-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗