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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01902342

Acronym

CES1

Enrollment

Registered

2013-07-18

Start date

2013-07-31

Completion date

2013-12-31

Last updated

2014-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGOseltamivir 75 mg 1 cap

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Oseltamivir pharmacokinetic parameters	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	Up to 0 to 48 h post dose	Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)

Secondary

Measure	Time frame	Description
Other oseltamivir pharmacokinetic parameters	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	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026