A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Oseltamivir 75 mg 1 cap (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s): Kyoung Soo Lim, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital
Summary
Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy
Korean volunteers.
Clinical Details
Official title: A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Pharmacokinetic Characteristics of Oseltamivir in Healthy Korean Volunteers
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Oseltamivir pharmacokinetic parametersOseltamivir carboxylate pharmacokinetic parameters
Secondary outcome: Other oseltamivir pharmacokinetic parametersOther oseltamivir carboxylate pharmacokinetic parameters
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Healthy subjects:
1. Agreement with written informed consent
2. Adult healthy male or female subject age 20 to 45
Exclusion Criteria:
1. Clinically significant, active gastrointestinal system, cardiovascular system,
pulmonary system, renal system, endocrine system, blood system, digestive system,
central nervous system, mental disease or malignancy
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
Locations and Contacts
Seoul National University Hospital Clinical Trial Center, Seoul 110-768, Korea, Republic of
Additional Information
Starting date: July 2013
Last updated: May 15, 2014
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