Phase 1 N=25 Randomized Basic Science

Effect of Delivery Route on PK of Sufentanil NanoTab

Pharmacokinetics

Bottom Line

View on ClinicalTrials.gov: NCT01639729 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: AUC (0 - Inf) — 273.8; 212.5; 163.4; 24.9 h.pg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Treatment A: Sufentanil IV (Drug); Treatment B: Sufentanil NanoTab Sublingual (Drug); Treatment C: Sufentanil NanoTab Buccal (Drug); Treatment D: Sufentanil NanoTab Oral (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Talphera, Inc
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY AUC (0 - Inf)	273.8; 212.5; 163.4; 24.9	—
PRIMARY Cmax	445.1; 58.9; 40.6; 4.3	—
PRIMARY Tmax	0.07; 0.85; 0.83; 1.11	—
PRIMARY CST 1/2	0.14; 2.28; 2.50; 2.00	—

Summary

Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.

Eligibility Criteria

Inclusion Criteria

body mass index 18 - 30

Exclusion Criteria

pregnant females
smokers
pulmonary disease
sleep apnea

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01639729). 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.