Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers
- Registration Number
- NCT01563432
- Lead Sponsor
- SK Chemicals Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description febuxostat (RT) Feburic® - febuxostat (TR) Feburic® - febuxostat (TR) TMX-67 - febuxostat (RT) TMX-67 -
- Primary Outcome Measures
Name Time Method Pharmacokinetic characteristics (AUClast and Cmax) 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 24 hours post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of