Clinical Study Report - Pilot Human Study to Assess the Pharmacokinetics, Safety and Tolerability of Inhalation Delivery of Zanamivir Hydrate

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11310%2F22%3A10452796" target="_blank" >RIV/00216208:11310/22:10452796 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11110/22:10452796
Result on the web
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DOI - Digital Object Identifier
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Result language
angličtina
Original language name
Clinical Study Report - Pilot Human Study to Assess the Pharmacokinetics, Safety and Tolerability of Inhalation Delivery of Zanamivir Hydrate
Original language description
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 All 6 subject absolved all periods, none was withdrawn from the study.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.
Czech name
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Czech description
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Project
<a href="/en/project/TP01010040" target="_blank" >TP01010040: The support of the process of commercialisation of research and development results at Charles University II</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year
2022
Confidentiality
C - Předmět řešení projektu podléhá obchodnímu tajemství (§ 504 Občanského zákoníku), ale název projektu, cíle projektu a u ukončeného nebo zastaveného projektu zhodnocení výsledku řešení projektu (údaje P03, P04, P15, P19, P29, PN8) dodané do CEP, jsou upraveny tak, aby byly zveřejnitelné.

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