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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Oseltamivir

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