Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Sibutramine-clopidogrel; Drug: sibutramine-Clarithromycin

• Registration Number: NCT01421706
• Lead Sponsor: Inje University

Brief Summary

Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects

Detailed Description

1. Plasma concentrations of sibutramine and its two active metabolites after single oral dose of sibutramine were determined in Korean healthy male subjects with different CYP2B6 genotypes (CYP2B6\*1/\*1, \*1/\*6 and \*6/\*6), either alone or after four-day pretreatment with clopidogrel or clarithromycin.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-22
• Study First Posted: 2011-08-23
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-16
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• must be healthy volunteer

Exclusion Criteria

• must not be under 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sibutramine-clopidogrel	Sibutramine-clopidogrel	sibutramine-clopidogrel
sibutramine-clarithromycin	sibutramine-Clarithromycin	sibutramine-clarithromycin

Primary Outcome Measures

Name	Time	Method
effects of clopidogrel and clarithromycin on the disposition of sibutramine	one year	the effects of clopidogrel and clarithromycin on the disposition of sibutramine and its two active metabolites M1 and M2 in vivo in relation to CYP2B6\*6 genetic polymorphism have been evaluated in Korean healthy subjects.