CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
Treatment A: Sufentanil IV +3 moredrug
Likely dose
Treatment A: Sufentanil IV 50 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01639729
NCT01639729Phase 1Completed

Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects

Talphera, Inc·interventional·Posted Jul 13, 2012·Updated Oct 1, 2015

In Brief

A Phase 1 clinical trial evaluating Treatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual, and 2 other interventions for Pharmacokinetics. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2012
Enrollment StartJul 1, 2012
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 14.0 years ago

Interventions

Treatment A: Sufentanil IVdrug

Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)

Treatment B: Sufentanil NanoTab Sublingualdrug

Single Sufentanil NanoTab 15 mcg given sublingually (SL)

Treatment C: Sufentanil NanoTab Buccaldrug

Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)

Treatment D: Sufentanil NanoTab Oraldrug

Single Sufentanil NanoTab 15 mcg swallowed (PO)