Pharmacologic Study of Oseltamivir in Healthy Volunteers (SEA002)

Mahidol University

Status and phase

Completed

Phase 1

Conditions

Avian Influenza A Virus

Treatments

Drug: oseltamivir

Drug: probenecid

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00439530

SEA Trial 0002

SEA ICRN

Details and patient eligibility

About

"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.

Enrollment

21 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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