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

NCT02470234 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-11-24

Study results available
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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.

Conditions

  • Attention-Deficit/Hyperactivity Disorder

Interventions

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

Sponsors & Collaborators

  • Rhodes Pharmaceuticals, L.P.

    lead INDUSTRY

Principal Investigators

  • Akwete Adjei, Ph.D. · Rhodes Pharmaceuticals, L.P.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-30
Primary Completion
2017-07-20
Completion
2017-08-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02470234 on ClinicalTrials.gov