NCT02002611

Drug-drug Interaction Study(Lobeglitazone, Warfarin)

Open Label, Randomized, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Lobeglitazone and Warfarin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and warfarin in healthy subjects.

Detailed description

From day 1 to day 12, lobeglitazone 0.5mg is administered daily to Group 1 subjects during period 1. Then on day 5,warfarin 25mg is co-administered Group 1 subjects at period 1. After 10 day-break, warfarin 25mg is administered Group 1 subjects at period 2. On period 2, lobeglitazone is not administered. Group 2 is administered in reverse order.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Lobeglitazone
DRUG	Warfarin

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-02-01
• Completion: 2014-05-01
• First posted: 2013-12-06
• Last updated: 2014-07-03

Locations

1 site across 1 country: South Korea