A Phase II, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of Modified Release Amphetamine (HLD100, Formulations B, C and E)) in Adolescents and Children With Attention-Deficit Hyperactivity Disorder (ADHD)

Phase 1/2 Completed 22 enrolled Ironshore Pharmaceuticals and Development, Inc

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to determine the rate and extent of absorption of one or more modified release formulations of amphetamine (HLD100) in both adolescents and children with ADHD.

Timeline

Start: 2013-07
Primary completion: 2013-09
Completion: 2013-09

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dextroamphetamine	Small molecule	30 mg	—

A Phase II, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of Modified Release Amphetamine (HLD100, Formulations B, C and E)) in Adolescents and Children With Attention-Deficit Hyperactivity Disorder (ADHD)

Summary

Timeline

Drugs

Indications