Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years With Attention-deficit/Hyperactivity Disorder
The objective of this study was to evaluate the plasma amphetamine concentration/time profile of amphetamine extended release oral suspension in children aged 4 to 5 years with attention-deficit/hyperactivity disorder, following a single 2.5 mg dose of amphetamine extended release oral suspension.
DYANAVEL® XR is an extended-release oral suspension that contains 2.5 mg/mL amphetamine base
(amphetamine extended-release oral suspension; AMPH EROS). Drug-resin complexation is formed
with the amphetamine and sodium polystyrene sulfonate, an ion exchange resin. The extended
release feature of the product is achieved by coating a portion of the drug/resin complexes
with an extended release coating. AMPH EROS contains approximately a 3.2:1 ratio of
d-amphetamine compared to l-amphetamine.
The objective of this study was to evaluate the plasma amphetamine concentration/time profile
of AMPH EROS in children aged 4 to 5 years with attention-deficit/hyperactivity disorder,
following a single 2.5 mg dose of AMPH EROS.
These data will guide appropriate dosing in planned safety and efficacy studies with AMPH
EROS in a preschool population with attention-deficit/hyperactivity disorder.
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