This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.
This study utilized a single-center, open-label, single-treatment, fasted design to examine the rate and extent of absorption of evening-administered HLD200 in children (6-12 years) and adolescents (13-17 years) with ADHD. Following a screening period that included five days washout to allow for clearance of any prior ADHD medications, subjects were domiciled in-clinic and administered HLD200 (B-formulation; 54 mg; oral capsule) at 9 pm under fasted conditions. Subjects were then observed for safety and tolerability and a total of 18 blood samples collected during a 48 hour period (at t=0, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24, 36 and 48 hours post-dosing). These samples were then assayed for methylphenidate plasma concentrations and this data used for calculation of pharmacokinetic parameters.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Centre for Psychiatry & Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
PK Parameters for Rate and Extent of Absorption of MPH: Lag Time
The absorption lag time for methylphenidate in plasma expressed in hours is the difference in time between the drug administration and the last time point where the drug concentration was below the limit of assay quantitation.
Time frame: 48hrs
PK Parameters for Rate and Extent of Absorption of MPH: Cmax
The maximum drug concentration of methylphenidate in plasma.
Time frame: 48hrs
PK Parameters for Rate and Extent of Absorption of MPH: Tmax
The time to reach maximum concentration of methylphenidate in plasma.
Time frame: 48hrs
PK Parameters for Rate and Extent of Absorption of MPH: AUC0-tz
Area under the methylphenidate plasma concentration-time curve to time point tz (AUC0-tz), where tz was the last time point over the time interval with a measurable drug concentration
Time frame: 48hrs
PK Parameters for Rate and Extent of Absorption of MPH: AUC0-inf
The area under the methylphenidate plasma concentration-time curve to infinite time
Time frame: 48hrs
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