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Pharmacologic Study of Oseltamivir in Healthy Volunteers

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Avian Influenza A Virus

Intervention: oseltamivir (Drug); probenecid (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Yupaporn Wattanagoon, DTM & H, Principal Investigator, Affiliation: Associate Professor, Department of Clinical Tropical Medicine Faculty of Tropical Medicine, Mahidol University

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.

Clinical Details

Official title: Pharmacologic Study of Oseltamivir in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: AUC 0-12 hrs.

Secondary outcome:

AUC 12-24 hrs.

C max

t max

t 1/2

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Bangkok Hospital for Tropical Diseases Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand
Additional Information

Starting date: November 2006
Last updated: July 24, 2009

Page last updated: August 23, 2015

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