Status:

COMPLETED

A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir

Lead Sponsor:

Seoul National University Hospital

Conditions:

Healthy

Eligibility:

All Genders

20-45 years

Phase:

PHASE1

Brief Summary

Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy Korean volunteers.

Eligibility Criteria

Inclusion

  • Healthy subjects:
  • Agreement with written informed consent
  • Adult healthy male or female subject age 20 to 45

Exclusion

  • Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
  • Medication with any drug which may affect the pharmacokinetics of oseltamivir within 14 days
  • Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
  • Subject with known for hypersensitivity reactions to oseltamivir
  • Subject who perform contraception during study periods
  • Female woman who are pregnant or are breast feeding
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Key Trial Info

Start Date :

July 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT01902342

Start Date

July 1 2013

End Date

December 1 2013

Last Update

May 19 2014

Active Locations (1)

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1

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea, 110-768