Trials / Completed
CompletedNCT00989404
Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days
A Randomized, Placebo Controlled, 3-Way Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo 10mg Administered Twice Daily for 5 Days by a Rotahaler Compared to the Diskhaler in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanamivir | Rotahaler placebo 10mg BID 5 days |
| DRUG | Zanamivir | Rotahaler Zanamivir 10mg BID 5 days |
| DRUG | Zanamivir | Diskhaler Zanamivir 10mg BID 5 days |
Timeline
- Start date
- 2009-10-12
- Primary completion
- 2009-12-07
- Completion
- 2009-12-07
- First posted
- 2009-10-05
- Last updated
- 2017-06-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00989404. Inclusion in this directory is not an endorsement.