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NCT00444028 · ClinicalTrials.gov registry record · Phase 1
Staccato Loxapine Single Dose PK
A Phase 1 study, sponsored by Alexza Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00444028: Completed Phase 1 study, sponsored by Alexza Pharmaceuticals.
NCT00444028 is a Phase 1 study that has completed, run by Alexza Pharmaceuticals. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00444028, a Phase 1 study, has completed, sponsored by Alexza Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers.
Primary Outcome
Tmax = time from inhalation to to maximum observed loxapine concentration
Interventions
- DRUG inhaled Loxapine 0.625 mg
- DRUG inhaled Loxapine 1.25 mg
- DRUG inhaled Loxapine 2.5 mg
- DRUG inhaled Loxapine 5 mg
- DRUG inhaled Loxapine 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2005-09 |
| Est. Completion | 2005-11 |
| Phase | Phase 1 |
What the finished NCT00444028 record still lists
NCT00444028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which inhaled Loxapine 0.625 mg is the first listed.
NCT00444028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00444028 about?
NCT00444028 is a clinical study titled "Staccato Loxapine Single Dose PK". The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers.
What is the current status of trial NCT00444028?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2005-09. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00444028?
The interventions under investigation include: inhaled Loxapine 0.625 mg (DRUG), inhaled Loxapine 1.25 mg (DRUG), inhaled Loxapine 2.5 mg (DRUG), inhaled Loxapine 5 mg (DRUG), inhaled Loxapine 10 mg (DRUG).
Who is sponsoring clinical trial NCT00444028?
This trial is sponsored by Alexza Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00444028's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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