Phase 1 Completed N=25 Randomized Basic Science

Effect of Delivery Route on PK of Sufentanil NanoTab

Pharmacokinetics

Source: ClinicalTrials.gov NCT01639729 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

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

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.

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	—

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. Informational only — not medical advice.