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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


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 parameters

Oseltamivir carboxylate pharmacokinetic parameters

Secondary outcome:

Other oseltamivir pharmacokinetic parameters

Other oseltamivir carboxylate pharmacokinetic parameters


Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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