Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized adults with influenza: an open-label, multicenter, single-arm, phase II study.

Evaluation of safety and efficacy of intravenous zanamivir in the treatment of hospitalized Japanese patients with influenza: an open-label, single-arm study.

BACKGROUND Zanamivir is a neuraminidase (NA) inhibitor used for the treatment of influenza. There is an unmet need for a parenteral influenza antiviral therapy to treat hospitalized patients. Therefore the safety and efficacy profile of intravenous zanamivir (IVZ) was examined in Japanese patients with severe influenza. METHODS The primary objective of this study was to evaluate the safety of...

Efficacy and Safety of Aripiprazole for Treatment of Irritability in Children with Autistic Disorder: An Open-Label Study

Safety, tolerability and pharmacokinetics of orally inhaled zanamivir: a randomized study comparing Rotacap/Rotahaler and Rotadisk/Diskhaler in healthy adults.

BACKGROUND During a pandemic, the need for available anti-influenza medications increases. There has been extensive use of the approved zanamivir Rotadisk/Diskhaler but no clinical data are available for administration by an alternative Rotacap/Rotahaler presentation. METHODS In this randomized three-way crossover study, each healthy adult received zanamivir 10 mg every 12 h for 5 days via Ro...

Pharmacokinetics and Bioavailability Comparison of two oral Tablet Formulations of Escitalopram 20 mg: A Single-Dose, Open-Label, Two-Period Crossover Study in Healthy Indian Adult Subjects

This study was done to assess bioequivalence between test and reference formulations of escitalopram oxalate 20 mg in healthy Indian male subjects. This single-dose, randomized, open-label, 2-period crossover study was carried out in 12 Healthy Indian Male volunteers aged 18 to 55 years under fasting conditions with a wash out of 14 days.  The subjects were randomly assigned to receive the test...

A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients

BACKGROUND Oral antipyretics are commonly used to treat pediatric patients who develop fevers. However, patients presenting to the emergency department or undergoing surgery are frequently unable to tolerate oral antipyretics. Rectal formulations are available; however, this route of administration is unpredictable. The main objectives of this randomized controlled study was to evaluate the eff...