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Completed

NCT Number: NCT00439530

Pharmacologic Study of Oseltamivir in Healthy Volunteers

"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.

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Key information

Conditions

Avian Influenza A Virus Animal Diseases Bird Diseases Infections Influenza in Birds Orthomyxoviridae Infections RNA Virus Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bangkok Hospital for Tropical Diseases Research Unit, Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oseltamivir

Drug

Probenecid

Drug

Primary outcomes

  1. AUC 0-12 hrs.

    Time frame: 12 hour

Secondary outcomes

  1. AUC 12-24 hrs.

    Time frame: 24 hrs

  2. C max

    Time frame: 24 hrs

  3. t max

    Time frame: 24 hrs

  4. t 1/2

    Time frame: 24 hrs

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Southeast Asia Influenza Clinical Research Network

Registry information

Acronym: SEA002

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 23, 2007
Registry last updated
Jul 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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