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CompletedNCT00439530SEA002Updated Jul 28, 2009

Pharmacologic Study of Oseltamivir in Healthy Volunteers

A Phase 1 interventional study of oseltamivir and probenecid in Avian Influenza A Virus, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-28.

Sponsored by Mahidol University · Phase 1, Interventional, and Health services research

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Avian Influenza A Virus

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Keywords

  • oseltamivir
  • pharmacokinetics
  • probenecid
  • avian influenza
03

In context

Influenza in Birds

113 studies on the registry are indexed under Influenza in Birds; 3 are open to participants now.

This study's enrollment of 21 is below the median of 157 across 103 interventional studies indexed under Influenza in Birds.

Browse Influenza in Birds studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Interventions

  • Drugoseltamivir
  • Drugprobenecid
06

What researchers measure

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

07

Study locations

1 site
  • Bangkok Hospital for Tropical Diseases Research Unit, Faculty of Tropical Medicine, Mahidol University
    Bangkok, 10400, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00439530
Lead sponsor
Mahidol University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Southeast Asia Influenza Clinical Research Network
First posted
Feb 23, 2007
Start date
Nov 2006
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Jul 28, 2009

Study contacts

Yupaporn Wattanagoon, DTM & H
principal investigator · Associate Professor, Department of Clinical Tropical Medicine Faculty of Tropical Medicine, Mahidol University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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