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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

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Oseltamivir 75 mg 1 cap Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Pharmacokinetic Characteristics of Oseltamivir in Healthy Korean Volunteers
Study Start Date : July 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oseltamivir

Arm Intervention/treatment
Experimental: CES1 gene variant group
Oseltamivir 75 mg 1 cap
Drug: Oseltamivir 75 mg 1 cap
Other Name: Tamiflu

Experimental: CES1 gene wild type group
Oseltamivir 75 mg 1 cap
Drug: Oseltamivir 75 mg 1 cap
Other Name: Tamiflu




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902342


Locations
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Korea, Republic of
Seoul National University Hospital Clinical Trial Center
Seoul, Korea, Republic of, 110-768
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Kyoung Soo Lim, MD, PhD Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01902342     History of Changes
Other Study ID Numbers: CES01
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
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Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action