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

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oseltamivir 75 mg 1 cap

Study type: Interventional

Funder types: Other

Identifiers

NCT01902342

CES01

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

CES1 gene variant group

Experimental group

Description:

Oseltamivir 75 mg 1 cap

Treatment:

Drug: Oseltamivir 75 mg 1 cap

CES1 gene wild type group

Experimental group

Description:

Oseltamivir 75 mg 1 cap

Treatment:

Drug: Oseltamivir 75 mg 1 cap