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Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years

NCT03610464 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-06-25

Study results available
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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.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Amphetamine Extended Release Suspension [Dyanavel]

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

Sponsors & Collaborators

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Antonio Pardo, MD · Tris Pharma, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2018-05-23
Completion
2018-05-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03610464 on ClinicalTrials.gov