Actively Recruiting
A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2025-04-10
20
Participants Needed
2
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
- Agree to use medically recognized contraception methods from the first administration until at least 6 months after the last dose
- Willing to voluntarily participate and provide written informed consent after full explanation of the trial
You will not qualify if you...
- Pregnant or suspected pregnant women, or lactating women
- Use of contraindicated drugs with the investigational product from 2 weeks before participation until the study ends
- Unable to stop consuming foods or diets affecting drug metabolism (e.g., grapefruit) from 48 hours before first dose until post-study visit
- Unable to discontinue other drugs affecting drug metabolism during the study (except investigational product), unless approved by investigator for adverse event treatment
- Participation in other clinical trials with investigational products within 4 weeks prior to first dose, or insufficient washout period based on drug half-life
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Asan Medical Center
Seoul, South Korea
Actively Recruiting
2
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Shin-young Oh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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