CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 5 enrolled
Drug / intervention
Amphetamine Extended Release Suspension [Dyanavel]drug
Likely dose
Amphetamine Extended Release Suspension [Dyanavel] 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03610464
NCT03610464Phase 4Completed
CompareCT.gov

Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years With Attention-deficit/Hyperactivity Disorder

Tris Pharma, Inc.·interventional·Posted Aug 1, 2018·Updated Jun 25, 2019

In Brief

A Phase 4 clinical trial evaluating Amphetamine Extended Release Suspension [Dyanavel] for Attention Deficit Hyperactivity Disorder. Completed, enrolled 5 participants across 1 site.

Detailed Summary

The objective of this study was to evaluate the plasma amphetamine concentration/time profile of amphetamine extended release oral suspension in children aged 4 to 5 years with attention-deficit/hyperactivity disorder, following a single 2.5 mg dose of amphetamine extended release oral suspension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 1, 2018
Enrollment StartMay 7, 2018
Primary CompletionMay 23, 2018
TodayJul 2, 2026
Enrollment to primary: 16 daysPosted 7.9 years ago

Interventions

Amphetamine Extended Release Suspension [Dyanavel]drug

1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis