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Trial record 24 of 118 for:    oseltamivir

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

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ClinicalTrials.gov Identifier: NCT01902342
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE July 15, 2013
First Posted Date  ICMJE July 18, 2013
Last Update Posted Date May 19, 2014
Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01902342 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir
Official Title  ICMJE A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Pharmacokinetic Characteristics of Oseltamivir in Healthy Korean Volunteers
Brief Summary Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy Korean volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Oseltamivir 75 mg 1 cap
Other Name: Tamiflu
Study Arms  ICMJE
  • Experimental: CES1 gene variant group
    Oseltamivir 75 mg 1 cap
    Intervention: Drug: Oseltamivir 75 mg 1 cap
  • Experimental: CES1 gene wild type group
    Oseltamivir 75 mg 1 cap
    Intervention: Drug: Oseltamivir 75 mg 1 cap
Publications * Oh J, Lee S, Lee H, Cho JY, Yoon SH, Jang IJ, Yu KS, Lim KS. The novel carboxylesterase 1 variant c.662A>G may decrease the bioactivation of oseltamivir in humans. PLoS One. 2017 Apr 24;12(4):e0176320. doi: 10.1371/journal.pone.0176320. eCollection 2017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01902342
Other Study ID Numbers  ICMJE CES01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyoung Soo Lim, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP