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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

2014-08-27 03:18:53 | BioPortfolio

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.

Description

The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler to placebo within the Rotahaler presentation and to the Diskhaler. Eighteen subjects will receive each of three treatments for 5 days in a 3-way crossover design.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Conditions

Influenza, Human

Intervention

Zanamivir, Zanamivir, Zanamivir

Location

GSK Investigational Site
Minneapolis
Minnesota
United States
55404

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:53-0400

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Medical and Biotech [MESH] Definitions

A guanido-neuraminic acid that is used to inhibit NEURAMINIDASE.

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

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Membrane glycoproteins from influenza viruses which are involved in hemagglutination, virus attachment, and envelope fusion. Fourteen distinct subtypes of HA glycoproteins and nine of NA glycoproteins have been identified from INFLUENZA A VIRUS; no subtypes have been identified for Influenza B or Influenza C viruses.

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