NCT05951946

A Study to Evaluate Drug-drug Interactions and Safety Between "BR3006-1", "BR3006-2", and "BR3006-3" in Healthy Volunteers

An Open Label, 6-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between "BR3006-1", "BR3006-2", and "BR3006-3" in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to evaluate drug-drug interactions and safety between "BR3006-1", "BR3006-2", and "BR3006-3" in healthy volunteers

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,D,E,F) assigned to each sequence group in Period 1, Period 2 and Period 3.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	BR3006-1	All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
DRUG	BR3006-2	All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
DRUG	BR3006-3	All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.

Timeline

• Start date: 2023-07-22
• Primary completion: 2023-09-11
• Completion: 2023-09-11
• First posted: 2023-07-19
• Last updated: 2023-10-31

Locations

1 site across 1 country: South Korea