Pharmacologic Study of Oseltamivir in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

"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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults

NCT00921726

Influenza Virus Diseases

COMPLETED PHASE1

Open-Label Pharmacokinetic of Oseltamivir in Healthy Obese Thai Adult Subjects

NCT01049763

Healthy

COMPLETED PHASE1

A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects

NCT00540501

Healthy Subjects

WITHDRAWN PHASE1

A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza

NCT01231620

Influenza, Human

COMPLETED PHASE3

Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults

NCT01314911

Influenza, Human

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Avian Influenza A Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

oseltamivir

Intervention Type DRUG

probenecid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes