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WithdrawnNCT00540501Updated May 31, 2010

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

A Phase 1 interventional study of Oseltamivir and Intravenous Zanamivir in Healthy Subjects, sponsored by GlaxoSmithKline. Withdrawn. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-31.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Contract agreement not reached
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Subjects

Keywords

  • zanamivir,
  • influenza virus,
  • healthy volunteer,
  • PK, drug interaction,
  • IV, and oseltamivir.
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion criteria:

  • Subjects with history of certain heart problems or subjects with Hepatitis B, C or HIV.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Oseltamivir 150mg and zanamivir 50mg/hour

    Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours

    Drug: Oseltamivir and Intravenous Zanamivir

  • Experimental
    Zanamivir IV 50mg/hour

    Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg)

    Drug: Oseltamivir and Intravenous Zanamivir

  • Experimental
    Oseltamivir 150mg and zanamivir 600mg

    Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h

    Drug: Oseltamivir and Intravenous Zanamivir

  • Active comparator
    Oseltamivir 150mg

    Oseltamivir 150mg PO q12h for 3 days

    Drug: Oseltamivir and Intravenous Zanamivir

Interventions

  • DrugOseltamivir and Intravenous Zanamivir

    Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3. Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3. Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.

06

What researchers measure

Primary outcomes

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

    Time frame: Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.

Secondary outcomes

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

    Time frame: Period 2-4 Day 1-3

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

    Time frame: Period 1, 3 & 4 Day 1-3

  3. Safety:labs, vitals, ECGs & AEs.

    Time frame: Period 1-4, Days 1-4.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00540501
Lead sponsor
GlaxoSmithKline
First posted
Oct 8, 2007
Start date
Oct 2007
Primary completion
Oct 2007 (estimated)
Completion
Oct 2007 (estimated)
Last update
May 31, 2010

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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