NCT02196805

A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1\*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1\*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.

Conditions

• Chinese Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Group A: imported Probucol ( Lorelco)	Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O.
DRUG	Group B: Marketed Probucol ( Chang Tai)	Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2014-07-22
• Last updated: 2014-07-22

Locations

1 site across 1 country: China