NCT05823870

This Study is to Compare and Evaluate the Safety and Pharmacokinetic Characteristics (PK) After Administration of DW6014 and Each Component(Empagliflozin and Metformin) in Healthy Adult Volunteers in Fast Condition.

A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of DW6014 and Loose Combination of Each Component in Healthy Adult Volunteers in Fasted Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Dong Wha Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6014 and each component in healthy adult volunteers in fast condition.

Detailed description

This is a Phase 1, randomized, open-label, Oral, Single-dose, two-way crossover study in healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	DW6014	Drug: DW6014 Single oral administration of DW6014 after an overnight fast Drug: Empagliflozin and Metformin Combination oral administration of Empagliflozin and Metformin after an overnight fast

Timeline

• Start date: 2023-02-24
• Primary completion: 2023-03-06
• Completion: 2023-03-20
• First posted: 2023-04-21
• Last updated: 2023-05-26

Locations

1 site across 1 country: South Korea