Last updated: 11/04/2018 09:21:56

A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects

GSK study ID
NAI108166
Clinicaltrials.gov ID
NCT00540501
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
Trial description: This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Oseltamivir carboxylate levels: Cmax and AUC(0-12)-

Timeframe: Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.

Secondary outcomes:

Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2.

Timeframe: Period 2-4 Day 1-3

Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 .

Timeframe: Period 1, 3 & 4 Day 1-3

Safety:labs, vitals, ECGs & AEs.

Timeframe: Period 1-4, Days 1-4.

Interventions:
  • Drug: Oseltamivir and Intravenous Zanamivir
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects
    Product
    zanamivir
    Collaborators
    GSK
    Study date(s)
    June 2009 to December 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy Volunteer(s)confirmed by physical exam, clinical labs, ECGs, and vitals
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy Volunteer(s)confirmed by physical exam, clinical labs, ECGs, and vitals
    • Must be woman of non-childbearing potential or willing to abstain from intercourse for two weeks prior to study drug administration and throughout the study or be willing to use two acceptable methods of birth control. Exclusion criteria:
    • Subjects with history of certain heart problems or subjects with Hepatitis B, C or HIV.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10400
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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