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

May 15, 2014 updated by: Seoul National University Hospital

A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Pharmacokinetic Characteristics of Oseltamivir in Healthy Korean Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-768
        • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CES1 gene variant group
Oseltamivir 75 mg 1 cap
Drug: Oseltamivir 75 mg 1 cap
Other Names:
  • Tamiflu
EXPERIMENTAL: CES1 gene wild type group
Oseltamivir 75 mg 1 cap
Drug: Oseltamivir 75 mg 1 cap
Other Names:
  • Tamiflu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oseltamivir pharmacokinetic parameters
Time Frame: Up to 0 to 48 h post dose
Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)
Up to 0 to 48 h post dose
Oseltamivir carboxylate pharmacokinetic parameters
Time Frame: Up to 0 to 48 h post dose
Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)
Up to 0 to 48 h post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other oseltamivir pharmacokinetic parameters
Time Frame: Up to 0 to 48 h post dose
first time to reach Cmax (tmax), terminal half-life (t1/2z), apparent clearance (CL/F), apparent renal clearance (CLR/F), metabolic ratio
Up to 0 to 48 h post dose
Other oseltamivir carboxylate pharmacokinetic parameters
Time Frame: Up to 0 to 48 h post dose
first time to reach Cmax (tmax), terminal half-life (t1/2z), apparent clearance (CL/F), apparent renal clearance (CLR/F), metabolic ratio
Up to 0 to 48 h post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Kyoung Soo Lim, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (ESTIMATE)

July 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CES01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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