NCT07083388

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

A total of 52 healthy volunteers will be enrolled to evaluate the pharmacokinetics and safety profiles of the study drug (one combination tablet of dapagliflozin 10 mg/pioglitazone 30 mg/metformin HCl 1000 mg) and the comparator (co-administration of dapagliflozin 10 mg, pioglitazone 30 mg, and metformin HCl 1000 mg, one tablet each, respectively) while fasting.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-07-03
• Primary completion: 2026-07-03
• Completion: 2026-07-03
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: South Korea