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Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

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ClinicalTrials.gov Identifier: NCT01761565
Recruitment Status : Completed
First Posted : January 7, 2013
Results First Posted : February 11, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.

Study Description
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Brief Summary:
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects
Study Start Date : January 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

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Arms and Interventions
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Arm Intervention/treatment
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™


Outcome Measures
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Primary Outcome Measures :
  1. 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


  2. 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)

  3. CST½ [ Time Frame: 24 ]
    the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761565


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

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Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01761565     History of Changes
Other Study ID Numbers: IAP101
First Posted: January 7, 2013    Key Record Dates
Results First Posted: February 11, 2015
Last Update Posted: October 1, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics