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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Oseltamivir 75 mg 1 cap

• Registration Number: NCT01902342
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-18
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-15
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Healthy subjects:

1. Agreement with written informed consent
2. Adult healthy male or female subject age 20 to 45

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CES1 gene variant group	Oseltamivir 75 mg 1 cap	Oseltamivir 75 mg 1 cap
CES1 gene wild type group	Oseltamivir 75 mg 1 cap	Oseltamivir 75 mg 1 cap

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of