NCT05403281

A Pharmacokinetic Study of DW6012 (FDC of Dapagliflozin and Sitagliptin) 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 DW6012 and Loose-combination of Each Component in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (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 DW6012 and each component in healthy adult volunteers.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	DW6012	Drug: DW6012 Single oral administration of DW6012 after an overnight fast Drug: Dapagliflozin and Sitagliptin Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast

Timeline

• Start date: 2021-11-05
• Primary completion: 2021-12-03
• Completion: 2022-03-28
• First posted: 2022-06-03
• Last updated: 2022-06-03

Locations

1 site across 1 country: South Korea