NCT06867497

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 74 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Adenocarcinoma of the Pancreas

Interventions

Type	Name	Description
DRUG	BR2021	intravenous administration for 30 minutes
DRUG	BR2021-1	intravenous administration for 30 minutes

Timeline

• Start date: 2025-02-24
• Primary completion: 2025-10-28
• Completion: 2025-10-28
• First posted: 2025-03-10
• Last updated: 2025-04-10

Locations

2 sites across 1 country: South Korea