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

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

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

must be healthy volunteer

Exclusion criteria

must not be under 18 years old

Treatment and study plan

Sibutramine-clopidogrel

Drug

Sibutramine-clopidogrel

sibutramine-Clarithromycin

Drug

sibutramine-Clarithromycin

Primary outcomes

effects of clopidogrel and clarithromycin on the disposition of sibutramine

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism

Acronym: sibu

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Aug 23, 2011
Registry last updated: Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed