8 results
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…
The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…
The objective of this study is to investigate the extent of respiratory depression at equi-analgesic dosages of tapentadol and oxycodone
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.
The Primary objective is to confirm the maintenance of vigilance with SENS-111.Secondary objectives are:* to confirm the maintenance of working memory, and cognitive function; * to confirm the pharmacodynamics effect of SENS-111 on symptoms…
In the current study we will measure ventilatory response, as assessed by ventilatory carbon dioxide responses to the administration of oxycodone during three conditions: a *low alcohol condition*, a *high alcohol condition* and a *no alcohol…
In this study we will measure the effect of Bedrocan which contains primarily *9-tetrahydrocannabinol (THC) and a minute quantity cannabidiol (CBD), on ventilation at 55 mmHg end-tidal PCO2 in 20 healthy volunteers and the combination of THC and 20…
The objective of the study is to quantify the effect of pregabaline and lacosamide on oxycodone-induced respiratory depression.