NCT05874167

A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers

A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of DW6013 and Loose Combination of Each Component in Healthy Adult Volunteers in Fast Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (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 DW6013 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	DW6013	Drug: DW6013 Single oral administration of DW6013 after an overnight fast Drug: Linagliptin and Metformin Single oral administration of Linagliptin and Metformin after an overnight fast

Timeline

• Start date: 2022-08-08
• Primary completion: 2022-10-11
• Completion: 2022-10-11
• First posted: 2023-05-24
• Last updated: 2023-05-24

Locations

1 site across 1 country: South Korea