2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.
Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
methylphenidate HCl ERCT
PK parameter-Tmax
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Time frame: 2 weeks
PK parameter- Cmax
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Time frame: 2 weeks
PK parameter- AUClast
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Time frame: 2 weeks
PK parameter-AUC0-2
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Time frame: 2 weeks
PK parameter-AUC2-6
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Time frame: 2 weeks
PK parameter-AUC6-24
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Time frame: 2 weeks
PK parameter-AUCinf
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Time frame: 2 weeks
PK parameter- t1/2
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Time frame: 2 weeks
PK parameter-CL/F
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
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Time frame: 2 weeks
PK parameter-Vz/F
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Time frame: 2 weeks
incidence of treatment emergent adverse events (safety and tolerability)
incidence of treatment emergent adverse events (safety and tolerability)
Time frame: 2 weeks