Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

This study has been completed.
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc. Identifier:
First received: January 3, 2013
Last updated: September 16, 2015
Last verified: September 2015
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs

Condition Intervention Phase
Plasma Concentrations
Drug: Single dose of SUF NT 15 mcg
Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by AcelRx Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Cmax [ Time Frame: 24 hours in Treatment A, 37 hours in Treatment B ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration

Enrollment: 40
Study Start Date: January 2013
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg

Period 1: Single dose of SUF NT 15 mcg

Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

Drug: Single dose of SUF NT 15 mcg Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Other Name: Zalviso™


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01761565

United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Principal Investigator: Sandra K. Willsie, D.O. PRA
  More Information

Responsible Party: AcelRx Pharmaceuticals, Inc. Identifier: NCT01761565     History of Changes
Other Study ID Numbers: IAP101
Study First Received: January 3, 2013
Results First Received: December 15, 2014
Last Updated: September 16, 2015
Health Authority: United States: Food and Drug Administration processed this record on November 25, 2015