NCT01426399

Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LC15-0444	LC15-0444 50mg qd (8 days once daily)
DRUG	Metformin	Metformin 1000 mg bid (8 days twice daily)
DRUG	LC15-0444+Metformin	LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2011-08-31
• Last updated: 2011-12-30

Locations

1 site across 1 country: South Korea