NCT05372380

A Study to Evaluate Drug-drug Interactions Between BR1017-1 and BR1017-2 in Healthy Volunteers

An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between "BR1017-1" and "BR1017-2" in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the influence of BR1017-1 and BR1017-2 on pharmacokinetics and safety when administered separately or co-administered to healthy volunteers.

Detailed description

A total of 32 subjects will be enrolled in one sequence group. The investigational products will be administered according to the treatment groups (F, AE, F+AE) assigned to one sequence group in Period 1, Period 2, and Period 3.

Conditions

• Hypertension
• Hypercholesterinemia

Interventions

Type	Name	Description
DRUG	BR1017-1	Administration to the F/F+AE group: BR1017-1 will be administered 1 tablet QD, five-day repeat dose
DRUG	BR1017-2	Administration to the AE group: BR1017-2 will be administered 1 tablet QD, 9-day repeat dose Administration to the F+AE group: BR1017-2 will be administered 1 tablet once QD, 5-day repeat dose.

Timeline

• Start date: 2022-05-09
• Primary completion: 2022-06-04
• Completion: 2022-06-30
• First posted: 2022-05-12
• Last updated: 2023-02-08

Locations

1 site across 1 country: South Korea