Phase 1
Completed N=54
Staccato Prochlorperazine Single Dose PK Study
Source: ClinicalTrials.gov NCT00610727 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Time to Peak (Tmax) — 0.042; 0.033; 0.025; 0.033 hours
Summary
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Peak (Tmax) |
0.042; 0.033; 0.025; 0.033; 0.040; 0.033 | — |
| SECONDARY Absolute Bioavailability of Inhaled Prochlorperazine |
0.98 | — |
| SECONDARY Dose Proportionality of Inhaled Prochlorperazine by Power Analysis |
1.089 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in good general health as determined by medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.
Exclusion Criteria
- Subjects with a known history of allergy or intolerance to phenothiazines or related drugs or who have any disease, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.
Data sourced from ClinicalTrials.gov (NCT00610727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.