Phase 1 N=19 Basic Science

Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

Pharmacokinetics

Bottom Line

View on ClinicalTrials.gov: NCT01721070 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: AUC (0-inf) — 126.47; 223.63 h*pg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Sufentanil NanoTab (SUF NT) 15 mcg (Drug); Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Talphera, Inc
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY AUC (0-inf)	126.47; 223.63	—
PRIMARY Cmax	39.95; 46.00	—

Summary

Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.

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 (NCT01721070). 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.