Phase 1 N=40 Basic Science

Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

Plasma Concentrations

Bottom Line

View on ClinicalTrials.gov: NCT01761565 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Cmax — 34.96; 249.55 pg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Single dose of SUF NT 15 mcg (Drug); 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Talphera, Inc
Primary completion: Feb 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Cmax	34.96; 249.55	—
PRIMARY Time to Steady State	4	—
PRIMARY CST½	2.17; 2.66	—

Summary

Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs

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

View full record on ClinicalTrials.gov →

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.