Who is sponsoring NCT02470234?

NCT02470234 is sponsored by Rhodes Pharmaceuticals, L.P..

What drugs are being tested in NCT02470234?

Interventions in NCT02470234: Methylphenidate HCl ER Capsules, 10 mg, Methylphenidate HCl ER Capsules, 15 mg, Methylphenidate HCl ER Capsules, 20 mg.

What condition does NCT02470234 study?

NCT02470234 studies Attention-Deficit/Hyperactivity Disorder.

Is NCT02470234 still recruiting?

NCT02470234 is currently completed. Last updated 24 November 2021.

Are results published for NCT02470234?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-11-24 · How we verify

NCT02470234: PK003

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 24 November 2021

What this trial tests

Phase 4 trial testing Methylphenidate HCl ER Capsules, 10 mg in Attention-Deficit/Hyperactivity Disorder in 10 participants. Completed in 7 August 2017.

Timeline

30 July 2016

Primary endpoint
20 July 2017

7 August 2017

Quick facts

Lead sponsor	Rhodes Pharmaceuticals, L.P.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	10
Start date	30 July 2016
Primary completion	20 July 2017
Estimated completion	7 August 2017
Sites	2 locations across United States

Drugs / interventions tested

Methylphenidate HCl ER Capsules, 10 mg — full drug profile →
Methylphenidate HCl ER Capsules, 15 mg — full drug profile →
Methylphenidate HCl ER Capsules, 20 mg — full drug profile →

Conditions studied

Attention-Deficit/Hyperactivity Disorder — all drugs for Attention-Deficit/Hyperactivity Disorder →

Sponsor

Rhodes Pharmaceuticals, L.P. — full company profile →

Who can join

Adults 4 to 5, any sex, with Attention-Deficit/Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cmax Primary · Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Maximum plasma concentration

Group	Value	95% CI
Methylphenidate HCl ER 10 mg	8.07	± 1.702
Methylphenidate HCl ER 15 mg	10.09	± 0.620
Methylphenidate HCl ER 20 mg	15.45	± 1.061

AUC(0-t) Primary · Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Area under the plasma concentration versus time curve (calculated to the last measurable observation). AUC: Area Under the Curve

Group	Value	95% CI
Methylphenidate HCl ER 10 mg	89.18	± 25.047
Methylphenidate HCl ER 15 mg	118.49	± 18.211
Methylphenidate HCl ER 20 mg	155.95	± 35.209

AUC(0-inf) Primary · Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Area under the plasma concentration versus time curve, extrapolated to infinity. AUC: Area Under the Curve

Group	Value	95% CI
Methylphenidate HCl ER 10 mg	105.26	± 21.831
Methylphenidate HCl ER 15 mg	140.68	± 0
Methylphenidate HCl ER 20 mg	144.26	± 0

AUC/D Primary · Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Dose-normalized AUC0-t. AUC: Area Under the Curve

Group	Value	95% CI
Methylphenidate HCl ER 10 mg	8.92	± 2.505
Methylphenidate HCl ER 15 mg	7.90	± 1.214
Methylphenidate HCl ER 20 mg	7.80	± 1.760

CL/F Primary · Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Apparent clearance. CL: Clearance

Group	Value	95% CI
Methylphenidate HCl ER 10 mg	97.51	± 18.095
Methylphenidate HCl ER 15 mg	106.63	± 0
Methylphenidate HCl ER 20 mg Capsule	138.64	± 0

V(Dss)/F Primary · Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Volume of distribution

Group	Value	95% CI
Methylphenidate HCl ER 10 mg	682.49	± 182.605
Methylphenidate HCl ER 15 mg	1952.17	± 0
Methylphenidate HCl ER 20 mg	1396.96	± 0

Cmax/Dose Primary · Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Dose-normalized Cmax

Group	Value	95% CI
Methylphenidate HCl ER 10 mg	0.81	± 0.170
Methylphenidate HCl ER 15 mg	0.67	± 0.041
Methylphenidate HCl ER 20 mg	0.77	± 0.053

Tmax Secondary · Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Time to peak plasma concentration

Group	Value	95% CI
Methylphenidate HCl ER 10 mg	2.0	1.0 – 3.0
Methylphenidate HCl ER 15 mg	3.0	3.0 – 12.0
Methylphenidate HCl ER 20 mg	2.0	2.0 – 2.0

T1/2 Secondary · Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Elimination half-life

Group	Value	95% CI
Methylphenidate HCl ER 10 mg	4.80	± 0.466
Methylphenidate HCl ER 15 mg	12.69	± 0
Methylphenidate HCl ER 20 mg	6.98	± 0

Kel Secondary · Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Terminal elimination constant

Group	Value	95% CI
Methylphenidate HCl ER 10 mg	0.15	± 0.015
Methylphenidate HCl ER 15 mg	0.05	± 0
Methylphenidate HCl ER 20 mg	0.10	± 0

Adverse events — posted to ClinicalTrials.gov

Time frame: From check in until 24 hours post dose. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Methylphenidate HCl ER 10 mg

Serious: 0/5 (0%)

Deaths: 0/5

Methylphenidate HCl ER 15 mg

Serious: 0/3 (0%)

Deaths: 0/3

Methylphenidate HCl ER 20 mg

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (1 terms — click to expand)

Reaction	System	Methylphenidate HCl ER 10 mg	Methylphenidate HCl ER 15 mg	Methylphenidate HCl ER 20 mg
Upper respiratory tract infection	Infections and infestations	—	—	—

Data from ClinicalTrials.gov NCT02470234 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Diagnosis and Treatment Options for Preschoolers with Attention-Deficit/Hyperactivity Disorder.
Wigal S, Chappell P, Palumbo D, Lubaczewski S, et al · · 2020 · cited 14× · PMID 31967914 · DOI 10.1089/cap.2019.0116
A Pharmacokinetic Study of Methylphenidate Hydrochloride Multilayer Extended-Release Capsules (Aptensio XR<sup>®</sup>) in Preschool-Aged Children with Attention-Deficit/Hyperactivity Disorder.
Adjei AL, Chaudhary I, Kollins SH, Padilla A. · · 2020 · cited 4× · PMID 32776159 · DOI 10.1007/s40272-020-00409-z

Verify or expand the search:

Other recruiting trials for Attention-Deficit/Hyperactivity Disorder

Currently open trials in the same condition.

NCT07327775 — Fibromyalgia Disease Burden in Mothers of Children With Attention-Deficit/Hyperactivity Disorder · recruiting

Other Rhodes Pharmaceuticals, L.P. trials

Trials by the same sponsor.

NCT02683265 — A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD · Phase 4 · completed
NCT01269463 — Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02470234 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rhodes Pharmaceuticals, L.P.
Last refreshed: 24 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02470234.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing