Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years
|ClinicalTrials.gov Identifier: NCT03610464|
Recruitment Status : Completed
First Posted : August 1, 2018
Results First Posted : June 25, 2019
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Amphetamine Extended Release Suspension [Dyanavel]||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This was an open-label, single-site, single-dose one-period, one-treatment study in 5 pediatric subjects diagnosed with ADHD, otherwise healthy. Subjects received a single, 1 mL dose of AMPH EROS 2.5 mg/mL, from which PK was assessed over a 28 hour period.|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years With Attention-deficit/Hyperactivity Disorder|
|Actual Study Start Date :||May 7, 2018|
|Actual Primary Completion Date :||May 23, 2018|
|Actual Study Completion Date :||May 23, 2018|
Experimental: Study patients (AMPH EROS)
All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base
Drug: Amphetamine Extended Release Suspension [Dyanavel]
1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis
Other Name: DYANAVEL XR, amphetamine extended release oral suspension
- Plasma Concentrations of d- and L-amphetamine [ Time Frame: 0-28 hours postdose ]Plasma Concentration of d- and l-amphetamine measured at 0, 1, 3, 4, 6, 8, 10, 12, and 28 hours postdose.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610464
|United States, Florida|
|Meridien Research, Inc.|
|Maitland, Florida, United States, 32751|
|Study Director:||Antonio Pardo, MD||Tris Pharma, Inc.|