Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects (sibu)
This study has been completed.
Sponsor:
Inje University
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier:
NCT01421706
First received: August 22, 2011
Last updated: September 16, 2012
Last verified: September 2012
| Tracking Information | |||||
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| First Received Date ICMJE | August 22, 2011 | ||||
| Last Updated Date | September 16, 2012 | ||||
| Start Date ICMJE | July 2008 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01421706 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects | ||||
| Official Title ICMJE | Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism | ||||
| Brief Summary | Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 19 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01421706 | ||||
| Other Study ID Numbers ICMJE | 08-073 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jae-Gook Shin, Inje University | ||||
| Study Sponsor ICMJE | Inje University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Inje University | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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