5 results
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
The primary objective for this study is to compare the safety, tolerability and analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of 2 doses to placebo in subjects with pain due to osteoarthritis (OA…
Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.
Primary objective:To determine the effect of obesity (BMI > 40kg/m2) on the pharmacokinetics of micafungin and develop a dosing regimen for obese patients. Secondary objective:* To describe the pharmacokinetics of the approved dose of 200mg…
Primary objective:To assess, in an international pediatric study, the efficacy, in terms of event-free survival, of a combination of ATO and ATRA in newly diagnosed SR APL children and adolescents and to explore the safety and efficacy of a…