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Completed

NCT Number: NCT01902342

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

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

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital Clinical Trial Center

Seoul, 110-768, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy subjects:

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

Exclusion criteria

  • 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

Treatment and study plan

Oseltamivir 75 mg 1 cap

Drug

Other names: Tamiflu

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: CES1

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2013
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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