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NCT03329014 · ClinicalTrials.gov registry record · Phase 1
A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability
A Phase 1 study, sponsored by Paion UK.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03329014: Completed Phase 1 study, sponsored by Paion UK.
NCT03329014 is a Phase 1 study that has completed, run by Paion UK. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03329014, a Phase 1 study, has completed, sponsored by Paion UK.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
A prospective dose escalation, nine period cross-over trial assessing the safety, pharmacokinetics, bioavailability and pharmacodynamics of escalating doses of Remimazolam when administered intranasally as powder and solution in healthy subjects and compared to an intravenous control
Primary Outcome
Adverse events assessment will include: change in clinical laboratory assessments from baseline, change in vital signs from baseline, change in 12-lead electrocardiograms from baseline, drop in oxygen saturation measured using continuous pulse oximetry, nasal effect using the Nasal Effect Questionnaire (NEQ) and nose and throat examination. Adverse events with a respiratory or cardiovascular focus and adverse events related to effects seen with medications known to be associated with abuse will
Interventions
- DRUG Placebo
- DRUG Remimazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-05-15 |
| Est. Completion | 2017-06-14 |
| Phase | Phase 1 |
What the finished NCT03329014 record still lists
NCT03329014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03329014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03329014 about?
NCT03329014 is a clinical study titled "A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability". A prospective dose escalation, nine period cross-over trial assessing the safety, pharmacokinetics, bioavailability and pharmacodynamics of escalating doses of Remimazolam when administered intranasally as powder and solution in healthy subjects and compared to an intravenous control
What is the current status of trial NCT03329014?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-05-15. Estimated completion is 2017-06-14.
What interventions are being tested in trial NCT03329014?
The interventions under investigation include: Placebo (DRUG), Remimazolam (DRUG).
Who is sponsoring clinical trial NCT03329014?
This trial is sponsored by Paion UK, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03329014's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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