NCT05875259

A Clinical Trial Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

A Randomized, Open-label, Multiple-dose, 6-sequence, 3-treatment, 3-period, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic interaction and safety between BR1019-1 and BR1019-2 in healthy adult subjects.

Conditions

• Hypertension
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	BR1019-1	Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.
DRUG	BR1019-2	Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.
DRUG	BR1019-1 + BR1019-2	Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.

Timeline

• Start date: 2023-05-13
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2023-05-25
• Last updated: 2023-09-28

Locations

1 site across 1 country: South Korea