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NCT03610464 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years
A Phase 4 study, sponsored by Tris Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT03610464: Completed Phase 4 study, sponsored by Tris Pharma.
NCT03610464 is a Phase 4 study that has completed, run by Tris Pharma. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03610464, a Phase 4 study, has completed, sponsored by Tris Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
Plasma Concentration of d- and l-amphetamine measured at 0, 1, 3, 4, 6, 8, 10, 12, and 28 hours postdose.
Interventions
- DRUG Amphetamine Extended Release Suspension [Dyanavel]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2018-05-23 |
| Phase | Phase 4 |
What the finished NCT03610464 record still lists
NCT03610464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Amphetamine Extended Release Suspension [Dyanavel] is the first listed.
NCT03610464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03610464 about?
NCT03610464 is a clinical study titled "Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years". 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.
What is the current status of trial NCT03610464?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2018-05-07. Estimated completion is 2018-05-23.
What interventions are being tested in trial NCT03610464?
The interventions under investigation include: Amphetamine Extended Release Suspension [Dyanavel] (DRUG).
Who is sponsoring clinical trial NCT03610464?
This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03610464's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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