Clinical Study to Evaluate the Pharmacokinetic Characteri... | NCT01563432

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

NCT01563432

Sponsor

SK Chemicals Co., Ltd.

Status

Completed

Last Update Posted

Mar 27, 2012Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Gout

Interventions

Feburic®
TMX-67

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Mar 16, 2012

First Submission Date that Met QC Criteria

Mar 26, 2012

First Posted Date

Mar 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2012

Last Update Posted Date

Mar 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
febuxostat (TR)	Experimental		Drug: Feburic® Drug: TMX-67
febuxostat (RT)	Experimental		Drug: Feburic® Drug: TMX-67

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Feburic®	Drug	80 mg*1 tablet	febuxostat (RT) febuxostat (TR)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic characteristics (AUClast and Cmax)		0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 24 hours post-dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ji-Young Park, M.D., Ph.D.	Korea University Anam Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Anam Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006073	Gout
D033461	Hyperuricemia

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070657	Crystal Arthropathies

Browse Leaves

Not provided

Browse Branches

Not provided