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

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Gout

Treatments: Drug: TMX-67; Drug: Feburic®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563432

TMX-67_BE_I_2011

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

febuxostat (TR)

Experimental group

Treatment:

Drug: TMX-67

Drug: Feburic®

febuxostat (RT)

Experimental group

Treatment:

Drug: TMX-67

Drug: Feburic®