Pharmacologic Study of Oseltamivir in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00439530

Acronym

SEA002

Enrollment

Registered

2007-02-23

Start date

2006-11-30

Completion date

2007-04-30

Last updated

2009-07-28

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

Conditions

Avian Influenza A Virus

Keywords

oseltamivir, pharmacokinetics, probenecid, avian influenza

Brief summary

Pharmacologic Study of Oseltamivir in Healthy Volunteers is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical Diseases Research Unit, Faculty of Tropical Medicine, and commenced enrolling healthy volunteers on 23 November 2006. The duration of the study is expected to be approximately four months. The goals of this study are to assess the use of loading dose oseltamivir and the concomitant use of probenecid and to characterize the pharmacokinetic properties of oseltamivir in Thai subjects.

Interventions

DRUGoseltamivir

DRUGprobenecid

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy with no underlying chronic disease * normal baseline laboratory screening * no regular prescribed medication used in the past 30 days and no over-the-counter medication in the past week * agree to abstain from self-medication during the study * negative urine pregnancy test for females and agreement that they will not try to become pregnant until 1 month after the study is completed * only use non-hormonal methods of contraception for females * non-smoker for the last 30 days and for duration of the study * no consumption of alcohol for the last 30 days and for duration of the study * no use of recreational drugs for the last 30 days and for duration of the study

Exclusion criteria

* known hypersensitivity to oseltamivir and/or probenecid * Hepatitis B virus surface antigen positive * presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study

Design outcomes

Primary

Measure	Time frame
AUC 0-12 hrs.	12 hour

Secondary

Measure	Time frame
AUC 12-24 hrs.	24 hrs
C max	24 hrs
t max	24 hrs
t 1/2	24 hrs

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026