4 results
Primary Objective:To describe the total apparent CYP3A mediated clearance (Cl/F) of midazolam in the paediatric intensive care population from the age of 0 to 6 years, as surrogate marker of intestinal and hepatic CYP3A activity.Secondary Objectives…
To assess the efficacy of a single, oral, 3 grams (g) dose of zoliflodacin compared to a combination of a singleintramuscular (IM) 500 milligram (mg) dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment ofuncomplicated…
The primary objective of this study is to evaluate the effect of multiple doses of azithromycin, clarithromycin and ritonavir on the pharmacokinetics, safety and tolerability of a single oral 150 mg dose of ivacaftor in healthy controls and in…
Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…