Pharmacokinetics Study for Probucol

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: probucol

• Registration Number: NCT01000467
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Status Verified: 2009-10
• Study First Submitted: 2009-10-18
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-23
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	probucol	Group 2(probucol 500mg BID)
3	probucol	Group 3(Probucol 500mg once daily)
1	probucol	Group 1(Probucol 250mg)

Primary Outcome Measures

Name	Time	Method
Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.	1 month

Trial Locations

Locations (1)

Seoul national univeristy; 🇰🇷 Seoul, Korea, Republic of