NCT02470234

Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD

A Pharmacokinetic Study of Aptensio XR® (Methylphenidate Hydrochloride (HCl) Extended-release) Capsules in Male or Female Pre-School Children 4 to Under 6 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD) in Fed Condition

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rhodes Pharmaceuticals, L.P. · Industry
• Sex: All
• Age: 4 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules under fed conditions in male or female children 4 to under 6 years of age with ADHD.

Detailed description

This will be a multi-center, open-label, single-dose, study to assess the pharmacokinetics of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules in male and female children 4 to under 6 years of age with ADHD in fed condition. Screening Procedures: After obtaining written informed consent from parents, subjects will undergo a complete medical and medication history, demographic data (including sex, age, race, ethnicity, body weight (kg), height (cm), Body Mass Index (BMI) (kg/m2), physical examination, vital signs evaluation (sitting blood pressure, pulse rate, respiration rate, temperature and pulse oximetry), resting 12-lead electrocardiogram (ECG), clinical laboratory tests and concomitant medication within 28 days prior to receiving study drug. On Day 1: subjects will receive a single oral dose of Aptensio XR®.

Conditions

• Attention-Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Methylphenidate HCl ER Capsules, 10 mg	Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg administered once daily in the morning
DRUG	Methylphenidate HCl ER Capsules, 15 mg	Methylphenidate Hydrochloride Extended-Release Capsules, 15 mg administered once daily in the morning
DRUG	Methylphenidate HCl ER Capsules, 20 mg	Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg administered once daily in the morning

Timeline

• Start date: 2016-07-30
• Primary completion: 2017-07-20
• Completion: 2017-08-07
• First posted: 2015-06-12
• Last updated: 2021-11-24
• Results posted: 2021-11-24

Locations

2 sites across 1 country: United States