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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01563432
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gout Drug: Feburic® Drug: TMX-67 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2012
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563432


Locations
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Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co., Ltd.
Investigators
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Principal Investigator: Ji-Young Park, M.D., Ph.D. Korea University Anam Hospital
More Information
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Responsible Party: SK Chemicals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01563432    
Other Study ID Numbers: TMX-67_BE_I_2011
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: February 2012
Keywords provided by SK Chemicals Co., Ltd.:
crossover
pharmacokinetic
hyperuricemia
gout