NCT06289920

A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fasting Conditions in Healthy Adult Volunteers

An Open Label, Randomized, Fasting, Single Dose, 2-sequence, 2-period, Crossover Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult volunteers

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	BR3005	One tablet administered alone, Once a day
DRUG	BR3005-1	One tablet administered alone, Once a day
DRUG	BR3005-2	One tablet administered alone, Once a day

Timeline

• Start date: 2024-03-02
• Primary completion: 2024-03-28
• Completion: 2024-03-28
• First posted: 2024-03-04
• Last updated: 2024-05-24

Locations

1 site across 1 country: South Korea