NCT01000467

Pharmacokinetics Study for Probucol

A Randomized, Open-label, Single-center Clinical Trial to Evaluate the Safety and Pharmacokinetics of Probucol by Multiple Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	probucol	group 3: 250 mg 1 tablet in the morning and evening
DRUG	probucol	group 1: 250 mg
DRUG	probucol	group 2: 250 mg 2 tablets at once in the morning

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2009-10-23
• Last updated: 2022-03-04

Locations

1 site across 1 country: South Korea