NCT05097794

A Clinical Trial to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers

An Open-label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (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 pharmacokinetic interactions (Drug-Drug interaction) and safety between "BR1015-1" and "BR1015-2" in healthy volunteers.

Detailed description

\*Study Objective: After repeated administration of BR1015-1 and BR1015-2 for healthy volunteers, the pharmacokinetic interactions and safety are evaluated. \*Investigational Product (and regimen) 1. BR1015-1: Administration of BR1015-1 60 mg once a day for 5 days 2. BR1015-2: Administration of BR1015-2 1.5 mg once a day for 5 days 3. BR1015-1+BR1015-2: Co-administration of BR1015-1 60 mg and BR1015-2 1.5 mg once a day for 5 days

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	BR1015-1	\- Administration to the BR1015-1 group: 60 mg of BR1015-1 will be administered one tablet once a day, five-day repeated doses.
DRUG	BR1015-2	\- Administration to the BR1015-2 group: 1.5 mg of BR1015-2 will be administered one tablet once a day, five-day repeated doses.
DRUG	BR1015-1 + BR1015-2	\- Co-administration to the BR1015-1+BR1015-2 group: 60 mg of BR1015-1 one tablet and 1.5 mg of BR1015-2 one tablet will be co-administered once a day, five-day repeated doses.

Timeline

• Start date: 2021-08-16
• Primary completion: 2021-10-22
• Completion: 2021-10-22
• First posted: 2021-10-28
• Last updated: 2021-11-22

Locations

1 site across 1 country: South Korea