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

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Oseltamivir 75 mg 1 cap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CES1 gene variant group<br>Oseltamivir 75 mg 1 cap | Drug: Oseltamivir 75 mg 1 cap<br> <br> * Other names: Tamiflu;|
| Experimental: CES1 gene wild type group<br>Oseltamivir 75 mg 1 cap | Drug: Oseltamivir 75 mg 1 cap<br> <br> * Other names: Tamiflu;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oseltamivir pharmacokinetic parameters | 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 | 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 | 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 | 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 |