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Pharmacologic Study of Oseltamivir in Healthy Volunteers (SEA002)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00439530
First Posted: February 23, 2007
Last Update Posted: July 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Southeast Asia Influenza Clinical Research Network
Information provided by:
Mahidol University
  Purpose
"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.

Condition Intervention Phase
Avian Influenza A Virus Drug: oseltamivir Drug: probenecid Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pharmacologic Study of Oseltamivir in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • AUC 0-12 hrs. [ Time Frame: 12 hour ]

Secondary Outcome Measures:
  • AUC 12-24 hrs. [ Time Frame: 24 hrs ]
  • C max [ Time Frame: 24 hrs ]
  • t max [ Time Frame: 24 hrs ]
  • t 1/2 [ Time Frame: 24 hrs ]

Enrollment: 21
Study Start Date: November 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439530


Locations
Thailand
Bangkok Hospital for Tropical Diseases Research Unit, Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
National Institute of Allergy and Infectious Diseases (NIAID)
Southeast Asia Influenza Clinical Research Network
Investigators
Principal Investigator: Yupaporn Wattanagoon, DTM & H Associate Professor, Department of Clinical Tropical Medicine Faculty of Tropical Medicine, Mahidol University
  More Information

Responsible Party: Yupaporn Wattanagoon, Faculty of Tropical Medicine, Mahidol University
ClinicalTrials.gov Identifier: NCT00439530     History of Changes
Other Study ID Numbers: SEA Trial 0002
SEA ICRN
First Submitted: February 21, 2007
First Posted: February 23, 2007
Last Update Posted: July 28, 2009
Last Verified: November 2006

Keywords provided by Mahidol University:
oseltamivir
pharmacokinetics
probenecid
avian influenza

Additional relevant MeSH terms:
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Oseltamivir
Probenecid
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents