NCT01590901

Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects

The Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral doses of probucol in healthy male subjects.

Detailed description

This is a single dose, single period, multiple administration, open-labeled trial in one investigation center. The screening examination will be completed from Day -14 to Day -2 before investigational medicinal product (IMP) administration. The subjects will be hospitalized on Day -1. From Day 1 (the next day), the subjects will receive probucol twice daily (BID). for 14 consecutive days. On Day 18, the subjects can be discharged after the safety evaluation. The follow-up visit will occur on Day 6, 9, 12, 15, 19, 27 (totally 41 days) after the final dosing day.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Probucol	250mg (1 tablet) bid. p.o for 14 consecutive days

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-04-01
• Completion: 2013-01-01
• First posted: 2012-05-03
• Last updated: 2013-06-05

Locations

1 site across 1 country: China