NCT01761565 is a Phase 1 clinical trial of Single dose of SUF NT 15 mcg in Plasma Concentrations, sponsored by Talphera, Inc.

Who is sponsoring NCT01761565?

NCT01761565 is sponsored by Talphera, Inc.

What drugs are being tested in NCT01761565?

Interventions in NCT01761565: Single dose of SUF NT 15 mcg, 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes.

What condition does NCT01761565 study?

NCT01761565 studies Plasma Concentrations.

Is NCT01761565 still recruiting?

NCT01761565 is currently completed. Last updated 16 September 2015.

Are results published for NCT01761565?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-09-16 · How we verify

NCT01761565

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects

Completed Phase 1 Results posted Last updated 16 September 2015

What this trial tests

Phase 1 trial testing Single dose of SUF NT 15 mcg in Plasma Concentrations in 40 participants. Completed in 1 February 2013.

Timeline

1 January 2013

Primary endpoint
1 February 2013

1 February 2013

Quick facts

Lead sponsor	Talphera, Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	40
Start date	1 January 2013
Primary completion	1 February 2013
Estimated completion	1 February 2013
Sites	1 location across United States

Drugs / interventions tested

Single dose of SUF NT 15 mcg — full drug profile →
40 consecutive doses of SUF NT 15 mcg taken every 20 minutes — full drug profile →

Conditions studied

Plasma Concentrations — all drugs for Plasma Concentrations →

Sponsor

Talphera, Inc — full company profile →

Who can join

Adults 18 to 45, any sex, with Plasma Concentrations. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Cmax
Time frame: 24 hours in Treatment A, 37 hours in Treatment B
For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1. For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 114
Time to Steady State
Time frame: 24 hours
Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p \>0.05)
CST½
Time frame: 24
the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Talphera, Inc trials

Trials by the same sponsor.

NCT02662764 — Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01761565 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Talphera, Inc
Last refreshed: 16 September 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01761565.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing