NCT01001013

Pharmacokinetic Drug Interaction Between LC15-0444 and Pioglitazone After Oral Administration in Healthy Male Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to investigate the drug interaction between LC15-0444 and pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and pioglitazone are administered concomitantly and each alone in healthy male subjects.

Detailed description

This study is a randomized, open-label, three-treatment, three-period, three-sequence and crossover design in healthy volunteers to evaluate tolerability, safety and pharmacokinetics after the multiple administration of LC15-0444 and pioglitazone concomitantly or each alone. Eligibility for participation of this study will be determined by demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks(-21 d \~ -2 d) before drug administration(1 d). Eligible subjects will be randomized to one of three sequence groups. According to the characteristics of anti-diabetic drugs, it is expected to be administered with other anti-diabetic drugs. Therefore, Drug-Drug Interaction with Pioglitazone should be identified in this trial.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LC15-0444, Pioglitazone	LC15-0444 200 mg (100 mg x 2) qd (12 days once daily) Pioglitazone 30 mg (15 mg x 2) qd (12 days once daily) LC15-0444 200 mg (100 mg x 2) qd + pioglitazone 30 mg (15 mg x 2) qd (12 days once daily)

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2009-10-23
• Last updated: 2010-12-02

Locations

1 site across 1 country: South Korea