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

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.

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