NCT05460364

A Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1018-1 and BR1018-2 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 BR1018-1 and BR1018-2 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 characteristics and compare the safety and tolerability after repeated separate or combined administrations of BR1018-1 and BR1018-2 in healthy adults.

Detailed description

A total of 36 subjects will be randomized into 6 sequence groups, 6 subjects per sequence group. The Investigational Products wil be according to the treatment group (A,B,C) assigned to each sequence group in Period 1, Period 2 and Period 3.

Conditions

• Hypertension
• Hyperlipidemia (E.G., Hypercholesterolemia)

Interventions

Type	Name	Description
DRUG	BR1018-1	Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days. Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
DRUG	BR1018-2	Treatment group B : One tablet of BR1018-2 administered alone once daily for 9 days. Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.

Timeline

• Start date: 2022-08-04
• Primary completion: 2022-10-17
• Completion: 2022-10-17
• First posted: 2022-07-15
• Last updated: 2023-05-24

Locations

1 site across 1 country: South Korea