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

This study has been completed.
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier:
First received: August 22, 2011
Last updated: September 16, 2012
Last verified: September 2012
Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects

Condition Intervention Phase
Drug: Sibutramine-clopidogrel
Drug: sibutramine-Clarithromycin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism

Resource links provided by NLM:

Further study details as provided by Inje University:

Primary Outcome Measures:
  • effects of clopidogrel and clarithromycin on the disposition of sibutramine [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.

Enrollment: 20
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sibutramine-clopidogrel
Drug: Sibutramine-clopidogrel
Active Comparator: sibutramine-clarithromycin
Drug: sibutramine-Clarithromycin

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.

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • must be healthy volunteer

Exclusion Criteria:

  • must not be under 18 years old
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01421706

Sponsors and Collaborators
Inje University
Principal Investigator: JaeGook Shin, MD,PhD Inje University
  More Information

Responsible Party: Jae-Gook Shin, Professor, Inje University
ClinicalTrials.gov Identifier: NCT01421706     History of Changes
Other Study ID Numbers: 08-073 
Study First Received: August 22, 2011
Last Updated: September 16, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Inje University:

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Obesity Agents
Antidepressive Agents
Appetite Depressants
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protein Synthesis Inhibitors
Psychotropic Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on May 30, 2016