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NCT00402350 · ClinicalTrials.gov registry record · Phase 1
Staccato Fentanyl Single and Multidose PK
A Phase 1 study, sponsored by Alexza Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT00402350 is a Phase 1 study that has completed, run by Alexza Pharmaceuticals. The registered enrollment target is 51 participants.
The verdict
NCT00402350, a Phase 1 study, has completed, sponsored by Alexza Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2 is a randomized, doubleblind, placebo-controlled dose escalation of Staccato Fentanyl, evaluating multiple doses of fentanyl. The three primary aims of the Phase I clinical trial are to evaluate the pharmacokinetics (PK) and absolute bioavailability for Fentanyl, compare the Staccato Fentanyl PK profile to the IV fentanyl PK profile, and examine the tolerability and safety of Staccato Fentanyl in a non-opioid-tolerant, healthy volunteer population.
Interventions
- DRUG Inhaled Placebo
- DRUG Inhaled Fentanyl 25 mcg
- DRUG Intravenous Fentanyl 25 mcg
- DRUG Inhaled Fentanyl 25 mcg x 2
- DRUG Inhaled Fentanyl 25 mcg x 4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2006-04 |
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00402350
The ClinicalTrials.gov registry entry for NCT00402350 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexza Pharmaceuticals, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Inhaled Placebo is the first listed.
NCT00402350 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00402350 about?
NCT00402350 is a clinical study titled "Staccato Fentanyl Single and Multidose PK". The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2 is a randomized, doublebli...
What is the current status of trial NCT00402350?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2006-04. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00402350?
The interventions under investigation include: Inhaled Placebo (DRUG), Inhaled Fentanyl 25 mcg (DRUG), Intravenous Fentanyl 25 mcg (DRUG), Inhaled Fentanyl 25 mcg x 2 (DRUG), Inhaled Fentanyl 25 mcg x 4 (DRUG).
Who is sponsoring clinical trial NCT00402350?
This trial is sponsored by Alexza Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
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