Completed

NCT Number: NCT01761565

Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

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

Completed

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Key information

Conditions

Plasma Concentrations

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single dose of SUF NT 15 mcg

Drug

40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

Drug

Other names: Zalviso™

Primary outcomes

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, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3
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

Sponsors and collaborators

Lead sponsor

Talphera, Inc

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jan 7, 2013
Registry last updated: Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.