Pharmacokinetics Study for Probucol | NCT01000467

Studies
Pharmacokinetics Study for Probucol

NCT01000467

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Mar 4, 2022Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Healthy

Interventions

probucol
probucol
probucol

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

Oct 2009

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

Feb 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Oct 18, 2009

First Submission Date that Met QC Criteria

Oct 21, 2009

First Posted Date

Oct 23, 2009Estimated

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

Feb 17, 2022

Last Update Posted Date

Mar 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.

Detailed Description

To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.

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 4

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
2	Active Comparator	Group 2(probucol 500mg BID)	Drug: probucol
1	Active Comparator	Group 1(Probucol 250mg)	Drug: probucol
3	Active Comparator	Group 3(Probucol 500mg once daily)	Drug: probucol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probucol	Drug	group 3: 250 mg 1 tablet in the morning and evening	3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Korean
Male
Age from 20 to 40 years at time of informed consent
BMI more than 19.0 and less than 25.0
Subjects who meet the following criteria at the time of the screening
Subjects with ECG results without AV block and with both of qTc and QRS width within the standard values

Exclusion criteria

History or clinical evidence of significant medical history
Present or previous significant drug allergy to any prescription or OTC medication

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung-Sang Yoo, MD, PhD	Clinical Trial Center, Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul national univeristy		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D011341	Probucol

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided