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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.
• Treatments: Febuxostat

Criteria

Inclusion Criteria:

• Healthy adult males aged between 20 and 45 years

• Subjects whose weight is 50 kg or more and BMI is between 18 and 29 kg/m2

• Subjects who were voluntarily decided to participate in the study and provided written informed consent to observe the directions

Exclusion Criteria:

• Medical history which may influence adsorption, distribution, metabolism, excretion of the drug

• Clinically significant active chronic disease(s)

• Persons who are deemed ineligible for the study by the investigator according to the clinical laboratory test results or for other reasons