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

Phase 1CompletedNCT01902342

Seoul National University Hospital20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Oseltamivir 75 mg 1 capDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Outcomes

Primary Outcomes

Oseltamivir pharmacokinetic parameters

Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)

Time frame: 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)

Time frame: Up to 0 to 48 h post dose

Secondary Outcomes

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

Time frame: 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

Time frame: Up to 0 to 48 h post dose

Data from ClinicalTrials.gov

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