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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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febuxostat (TR)

Group Type EXPERIMENTAL

Feburic®

Intervention Type DRUG

80 mg\*1 tablet

TMX-67

Intervention Type DRUG

40 mg\*2 tablets

febuxostat (RT)

Group Type EXPERIMENTAL

Feburic®

Intervention Type DRUG

80 mg\*1 tablet

TMX-67

Intervention Type DRUG

40 mg\*2 tablets

Interventions

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Feburic®

80 mg\*1 tablet

Intervention Type DRUG

TMX-67

40 mg\*2 tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes