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NCT01907360 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of HLD200 in Children and Adolescents With ADHD
A Phase 1 study, sponsored by Ironshore Pharmaceuticals and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01907360: Completed Phase 1 study, sponsored by Ironshore Pharmaceuticals and Development.
NCT01907360 is a Phase 1 study that has completed, run by Ironshore Pharmaceuticals and Development. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01907360, a Phase 1 study, has completed, sponsored by Ironshore Pharmaceuticals and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.
Primary Outcome
The absorption lag time for methylphenidate in plasma expressed in hours is the difference in time between the drug administration and the last time point where the drug concentration was below the limit of assay quantitation.
Interventions
- DRUG HLD200 (methylphenidate hydrochloride)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2013-08 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01907360 record still lists
NCT01907360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which HLD200 (methylphenidate hydrochloride) is the first listed.
NCT01907360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01907360 about?
NCT01907360 is a clinical study titled "Pharmacokinetics of HLD200 in Children and Adolescents With ADHD". This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.
What is the current status of trial NCT01907360?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2013-08. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01907360?
The interventions under investigation include: HLD200 (methylphenidate hydrochloride) (DRUG).
Who is sponsoring clinical trial NCT01907360?
This trial is sponsored by Ironshore Pharmaceuticals and Development, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01907360's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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