A Phase II, Two-Stage, Open-Label, Single-Treatment, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of up to Three Separate HLD100 Modified Release Formulations of Dextroamphetamine Sulfate in Adolescent (Stage 1) and Pediatric (Stage 2) Patients With Attention-Deficit Hyperactivity Disorder.

Ironshore Pharmaceuticals and Development, Inc1 site in 1 country22 target enrollmentJuly 2013

ConditionsAttention-Deficit Hyperactivity Disorder

InterventionsHLD100-B HLD100-C HLD100-E

DrugsHLD100-B HLD100-C HLD100-E

Overview

Phase: Phase 1
Intervention: HLD100-B
Conditions: Attention-Deficit Hyperactivity Disorder
Sponsor: Ironshore Pharmaceuticals and Development, Inc
Enrollment: 22
Locations: 1
Primary Endpoint: Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

September 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel