Status:
COMPLETED
Pharmacologic Study of Oseltamivir in Healthy Volunteers
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Southeast Asia Influenza Clinical Research Network
Conditions:
Avian Influenza A Virus
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00439530
Start Date
November 1 2006
End Date
April 1 2007
Last Update
July 28 2009
Active Locations (1)
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1
Bangkok Hospital for Tropical Diseases Research Unit, Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400