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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…
Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.
The primary objective is to examine whether a memory impairment as a result of biperiden treatment (cholinergic M1 antagonist) will be increased by acute tryptophan depletion (ATD, a drink that decreases serotonin synthesis). In other words, we will…
The primary objective is to examine whether a memory impairment as a result of biperiden treatment (cholinergic M1 antagonist) can be reversed by rivastigmine (a cholinesterase inhibitor). Secondary, we will assess the effects of biperiden and…
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…
• To determine the profile of CNS effects at several time points after 2 mg and 4 mg biperiden in comparison to placebo in healthy elderly subjects.• To investigate the safety and tolerability of biperiden in healthy elderly subjects.• To determine…
We will examine the cognitive performance of healthy young participants at different time points after a single administration of biperiden. The behavioural outcomes and electrophysiological correlates will be linked with the serum levels of…
- Characterization of the CNS PD profile of IV administered biperiden- Characterization of the pharmacokinetic profile of IV administered biperiden- To confirm the plasma concentration-effect relationship of biperiden using population PK-PD modeling…
To evaluate the efficacy of OT-101 Ophthalmic Solution in treating the progression of myopia in pediatric subjects following 3 years of treatment.To evaluate the safety and tolerability of OT-101 Ophthalmic Solution in pediatric subjects with myopia…