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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01563432
First received: March 16, 2012
Last updated: March 26, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Gout
 Drug: Feburic®
Drug: TMX-67
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
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:

MedlinePlus related topics: Gout
Drug Information available for: Febuxostat
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563432

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

No publications provided

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov 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
Health Authority: Korea: Food and Drug Administration

Keywords provided by SK Chemicals Co.,Ltd.:
crossover
pharmacokinetic
hyperuricemia
gout

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
 Genetic Diseases, Inborn
Metabolic Diseases
Febuxostat
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013