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

This study has been completed.
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd. Identifier:
First received: March 16, 2012
Last updated: March 26, 2012
Last verified: February 2012
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.

Condition Intervention Phase
Drug: Feburic®
Drug: TMX-67
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:
  • Pharmacokinetic characteristics (AUClast and Cmax) [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 24 hours post-dose ]

Enrollment: 30
Study Start Date: January 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: febuxostat (TR) Drug: Feburic®
80 mg*1 tablet
Drug: TMX-67
40 mg*2 tablets
Experimental: febuxostat (RT) Drug: Feburic®
80 mg*1 tablet
Drug: TMX-67
40 mg*2 tablets


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01563432

Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Principal Investigator: Ji-Young Park, M.D., Ph.D. Korea University Anam Hospital
  More Information

Responsible Party: SK Chemicals Co.,Ltd. Identifier: NCT01563432     History of Changes
Other Study ID Numbers: TMX-67_BE_I_2011
Study First Received: March 16, 2012
Last Updated: March 26, 2012

Keywords provided by SK Chemicals Co.,Ltd.:

Additional relevant MeSH terms:
Gout Suppressants
Antirheumatic Agents processed this record on May 22, 2017