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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 is a Phase 4 study that has completed, run by Tris Pharma. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03610464
The ClinicalTrials.gov registry entry for NCT03610464 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tris Pharma, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Amphetamine Extended Release Suspension [Dyanavel] is the first listed.
NCT03610464 reports 0 study locations.
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.
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