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Pharmacologic Study of Oseltamivir in Healthy Volunteers (SEA002)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Southeast Asia Influenza Clinical Research Network
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00439530
First received: February 21, 2007
Last updated: July 24, 2009
Last verified: November 2006
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pharmacologic Study of Oseltamivir in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • AUC 0-12 hrs. [ Time Frame: 12 hour ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
For Southeast Asia Influenza Clinical Research Network information and updates  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: February 21, 2007
Last Updated: July 24, 2009
Health Authority: United States: Federal Government

Keywords provided by Mahidol University:
oseltamivir
pharmacokinetics
probenecid
avian influenza

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

ClinicalTrials.gov processed this record on May 21, 2013