- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01563432
Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers
March 26, 2012 updated by: SK Chemicals Co., Ltd.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Korea University Anam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: febuxostat (TR)
|
80 mg*1 tablet
40 mg*2 tablets
|
Experimental: febuxostat (RT)
|
80 mg*1 tablet
40 mg*2 tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 24 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ji-Young Park, M.D., Ph.D., Korea University Anam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
March 16, 2012
First Submitted That Met QC Criteria
March 26, 2012
First Posted (Estimate)
March 27, 2012
Study Record Updates
Last Update Posted (Estimate)
March 27, 2012
Last Update Submitted That Met QC Criteria
March 26, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TMX-67_BE_I_2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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