NCT01563432

Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers

Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Febuxostat Between TMX-67 40mg 2 Tablets and Feburic® 80mg 1 Tablet in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study was designed to compare and evaluate the pharmacokinetic characteristics of febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in healthy adults; and to evaluate safety and tolerance following a single-dose administration.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Feburic®	80 mg\*1 tablet
DRUG	TMX-67	40 mg\*2 tablets

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-03-27
• Last updated: 2012-03-27

Locations

1 site across 1 country: South Korea