Pharmacokinetics of Zanamivir After Single and Repeated Dose Infusion Administration in Healthy Chinese Adults
Status:
Completed
Trial end date:
2015-06-19
Target enrollment:
Participant gender:
Summary
Zanamivir is a potent and highly selective inhibitor of the influenza virus neuraminidase.
Intravenous (IV) zanamivir is being developed for treatment of hospitalized patients with
influenza, especially for those patients who may be in greatest need of parenteral influenza
antiviral agents. This study is a pharmacokinetic (PK) study to evaluate the
safety/tolerability and pharmacokinetic profiles of IV zanamivir 300 milligrams (mg) and 600
mg in Chinese healthy subjects. Subjects will be randomized to receive either 300 mg or 600
mg IV zanamivir as a single dose followed by repeated dose every 12 hours (h) for 5 days.
Subjects will be contacted or will return to study center for a follow-up visit, 7 days after
the last dose or withdrawal from the study. Total number of subjects planned for enrollment
will be 24 such that approximately 10 subjects complete dosing and critical assessments in
each dose cohort. The total duration of the study will be approximately 6 weeks from
screening to follow-up.