It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation
does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc
prolongation following repeat dosing is unknown. Therefore the current study will assess the
potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours
apart, in relation to placebo and an active control in healthy volunteers.
The study hypothesis H0: Placebo-subtracted max mean dQTc > 10 msec
Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication
Teva Branded Pharmaceutical Products, R&D Inc.
This study is to assess the pharmacokinetics of loxapine and will be using plasma
concentration data obtained over 48 hours after administration of the study drug
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