A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fasting)

Sponsor
Boryung Pharmaceutical Co., Ltd
Study ID
NCT07083388
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

This was an open-label, randomized, fasting, single-dose, 2-sequence, 2-period crossover study to evaluate the pharmacokinetics and safety between single oral administration of "BR3006" and co-administration of "BR3006A", "BR3006B," and "BR3006C" in healthy adult volunteers.

Key Dates

Start date
Jul 3, 2025
Status verified
Jul 2025
Primary completion
Jul 3, 2026
Completion
Jul 3, 2026

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence A (R1+R2+R3 / T)
    R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006
  • Experimental: Sequence B (T / R1+R2+R3)
    T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C

Primary Outcome Measure

Pharmacokinetic variable - Cmax [ Time Frame: From Day 1, 0 hour (pre-dose) to Day 5 after dose administration ]

Central Contacts

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