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Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days

NCT00989404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-06-14

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler device presentation to placebo within the Rotahaler presentation and to the Diskhaler device.

Conditions

  • Influenza A Virus, H1N1 Subtype

Interventions

DRUG

Zanamivir

Rotahaler placebo 10mg BID 5 days

DRUG

Zanamivir

Rotahaler Zanamivir 10mg BID 5 days

DRUG

Zanamivir

Diskhaler Zanamivir 10mg BID 5 days

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-12
Primary Completion
2009-12-07
Completion
2009-12-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00989404 on ClinicalTrials.gov