NCT05411965

A Study to Evaluate the Pharmacokinetics After Administration of BR3003 and Co-administration of BR3003B and BR3003C.

A Randomized, Open-label, Single Dose, Two-way Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR3003" and Co-administration of "BR3003B" and "BR3003C" in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

To perform a comparative evaluation on the pharmacokinetics and the safety after administration of "BR3003" and co-administration of "BR3003B" and "BR3003C" in healthy adults.

Detailed description

A randomized, open-label, single oral dose, two-way crossover study under fasting condition. Target number of subjects: 46 subjects in total.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	BR3003(T)	Test drug (T):"BR3003" Boryung Pharmaceutical Co., Ltd.
DRUG	BR3003B(R1)	Reference drug 1 (R1): "BR3003B" of Celltrion Pharm, Inc.
DRUG	BR3003C(R2)	Reference drug 2 (R2): "BR3003C" of AstraZeneca Korea

Timeline

• Start date: 2022-04-28
• Primary completion: 2022-07-03
• Completion: 2022-07-03
• First posted: 2022-06-09
• Last updated: 2022-07-27

Locations

1 site across 1 country: South Korea