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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis
Meridien Research, Inc.
Maitland, Florida, United States
Plasma Concentrations of d- and L-amphetamine
Plasma Concentration of d- and l-amphetamine measured at 0, 1, 3, 4, 6, 8, 10, 12, and 28 hours postdose.
Time frame: 0-28 hours postdose
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