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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01421706
First Posted: August 23, 2011
Last Update Posted: September 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
  Purpose
Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 Jae-Gook Shin, Inje University:

Primary Outcome Measures:
  • 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.


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
sibutramine-clopidogrel
Drug: Sibutramine-clopidogrel
Sibutramine-clopidogrel
Active Comparator: sibutramine-clarithromycin
sibutramine-clarithromycin
Drug: sibutramine-Clarithromycin
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • must be healthy volunteer

Exclusion Criteria:

  • must not be under 18 years old
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421706


Sponsors and Collaborators
Inje University
Investigators
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
First Submitted: August 22, 2011
First Posted: August 23, 2011
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by Jae-Gook Shin, Inje University:
clarithromycin
sibutramine
clopidogrel

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