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

Sponsor
Boryung Pharmaceutical Co., Ltd
Study ID
NCT05951946
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BR3006-1 — DRUG
    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.
  • BR3006-2 — DRUG
    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.
  • BR3006-3 — DRUG
    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.

Study Details

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

Key Dates

First listed
Jul 19, 2023
Start date
Jul 22, 2023
Status verified
Oct 2023
Primary completion
Sep 11, 2023
Completion
Sep 11, 2023

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment 1(T1)
    BR3006-1 + BR3006-2 administered in combination once daily for 7 days.
  • Active Comparator: Treatment 2(T2)
    BR3006-3 administered alone once daily for 7 days.
  • Experimental: Treatment 3(T3)
    BR3006-1 + BR3006-2 + BR3006-3 administered in combination once daily for 7 days.

Primary Outcome Measure

AUCτ,ss [ Time Frame: Day 1 (0h), Day 5 (0h), Day 6 (0h), Day 7 (0h~14h) & Day 8 (0h), Day 9 (0h), Day 10 (0h) of each period ]

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