Phase 1
Completed N=40
Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
Plasma Concentrations
Source: ClinicalTrials.gov NCT01761565 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Cmax — 34.96; 249.55 pg/mL
Summary
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
34.96; 249.55 | — |
| PRIMARY Time to Steady State |
4 | — |
| PRIMARY CST½ |
2.17; 2.66 | — |
Eligibility Criteria
Inclusion Criteria
- Non smoking
- Ages 18 to 45 year, inclusive
- BMI between 18 and 30
Exclusion Criteria
- Subjects taking any prescription or OTC medications or vitamins or supplements
- Pregnant females
- Subjects with pulmonary disease or sleep apnea
Data sourced from ClinicalTrials.gov (NCT01761565). 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.