A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fed)
NCT07083401 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-07-24
Summary
This was an open-label, randomized, fed, 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.
Conditions
- Diabete Mellitus
Interventions
- DRUG
-
Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg
Orally administered once per day
- DRUG
-
Dapagliflozin 10 mg
Orally administered once per day
- DRUG
-
Pioglitazone 30 mg
Orally administered once per day
- DRUG
-
Metformin HCl 1000 mg
Orally administered once per day
Sponsors & Collaborators
-
Boryung Pharmaceutical Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-05
- Primary Completion
- 2026-07-05
- Completion
- 2026-07-05
Countries
- South Korea
Study Locations
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