A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir
NCT ID: NCT01902342
Last Updated: 2014-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2013-07-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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CES1 gene variant group
Oseltamivir 75 mg 1 cap
Oseltamivir 75 mg 1 cap
CES1 gene wild type group
Oseltamivir 75 mg 1 cap
Oseltamivir 75 mg 1 cap
Interventions
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Oseltamivir 75 mg 1 cap
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Agreement with written informed consent
2. Adult healthy male or female subject age 20 to 45
Exclusion Criteria
2. Medication with any drug which may affect the pharmacokinetics of oseltamivir within 14 days
3. Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
4. Subject with known for hypersensitivity reactions to oseltamivir
5. Subject who perform contraception during study periods
6. Female woman who are pregnant or are breast feeding
7. An impossible one who participates in clinical trial by investigator's decision including laboratory test result
20 Years
45 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Kyoung Soo Lim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital Clinical Trial Center
Seoul, , South Korea
Countries
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References
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Oh J, Lee S, Lee H, Cho JY, Yoon SH, Jang IJ, Yu KS, Lim KS. The novel carboxylesterase 1 variant c.662A>G may decrease the bioactivation of oseltamivir in humans. PLoS One. 2017 Apr 24;12(4):e0176320. doi: 10.1371/journal.pone.0176320. eCollection 2017.
Other Identifiers
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CES01
Identifier Type: -
Identifier Source: org_study_id
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