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

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ClinicalTrials.gov Identifier: NCT01421706
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects

Condition or disease Intervention/treatment Phase
Healthy Drug: Sibutramine-clopidogrel Drug: sibutramine-Clarithromycin Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : July 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: sibutramine-clopidogrel
sibutramine-clopidogrel
Drug: Sibutramine-clopidogrel
Sibutramine-clopidogrel
Active Comparator: sibutramine-clarithromycin
sibutramine-clarithromycin
Drug: sibutramine-Clarithromycin
sibutramine-Clarithromycin


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

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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 Posted: August 23, 2011    Key Record Dates
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