Clinical Study Report - Pilot Human Study to Assess the Pharmacokinetics, Safety and Tolerability of Inhalation Delivery of Zanamivir Hydrate
Abstract
This was a cross over pilot human study to assess the pharmacokinetics, safety and tolerability of inhalation ielivery of zanamivir hydrate. PK profiles have been described, bioavailability after nebulization was 17%.
No adverse or serious adverse events were observed during the clinical study. All physical examinations, ECGs, vital signs, laboratory assessments at the end of the study were within a range.
All 6 subject absolved all periods, none was withdrawn from the study. No concomitant medication was necessary to administer during the clinical study.
Thus, safety and tolerability of nebulized zanamivir hydrate in doses 10, 20 and 60 mg was shown.