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

Phase 4 Completed 10 enrolled Rhodes Pharmaceuticals, L.P.

Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

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

Publications

Adjei AL, Chaudhary I, Kollins SH, Padilla A. A Pharmacokinetic Study of Methylphenidate Hydrochloride Multilayer Extended-Release Capsules (Aptensio XR(R)) in Preschool-Aged Children with Attention-Deficit/Hyperactivity Disorder. Paediatr Drugs. 2020 Oct;22(5):561-570. doi: 10.1007/s40272-020-00409-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	10 mg	Oral
Subject	Methylphenidate	Small molecule	15 mg	Oral
Subject	Methylphenidate	Small molecule	20 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications