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Effect of Delivery Route on PK of Sufentanil NanoTab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01639729
First Posted: July 13, 2012
Last Update Posted: October 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
  Purpose
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.

Condition Intervention Phase
Pharmacokinetics Drug: Treatment A: Sufentanil IV Drug: Treatment B: Sufentanil NanoTab Sublingual Drug: Treatment C: Sufentanil NanoTab Buccal Drug: Treatment D: Sufentanil NanoTab Oral Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • AUC (0 - Inf) [ Time Frame: 24 hours ]
    total amount of sufentanil absorbed

  • Cmax [ Time Frame: 24 hours ]
    maximum plasma concentration

  • Tmax [ Time Frame: 24 hours ]
    time to maximum plasma concentration

  • CST 1/2 [ Time Frame: 24 hours ]
    time for maximum plasma concentration to decrease by 50%


Enrollment: 25
Study Start Date: July 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 - Treatment A, B, C, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)
Experimental: Sequence 2 - Treatment A, B, D, C
15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)
Experimental: Sequence 3 - Treatment A, C, B, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)
Experimental: Sequence 4 - Treatment A, C, D, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)
Experimental: Sequence 5 - Treatment A, D, B, C
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)
Experimental: Sequence 6 - Treatment A, D, C, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)

  Eligibility

Information from the National Library of Medicine

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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:

  • body mass index 18 - 30

Exclusion Criteria:

  • pregnant females
  • smokers
  • pulmonary disease
  • sleep apnea
  Contacts and Locations
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): NCT01639729


Locations
United States, Kansas
PRA
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Investigators
Study Director: Pamela Palmer, M.D. AcelRx Pharmaceuticals, Inc.
  More Information

Publications:
Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01639729     History of Changes
Other Study ID Numbers: IAP102
First Submitted: July 11, 2012
First Posted: July 13, 2012
Results First Submitted: November 25, 2013
Results First Posted: May 21, 2014
Last Update Posted: October 1, 2015
Last Verified: September 2015

Keywords provided by AcelRx Pharmaceuticals, Inc.:
pharmacokinetics
area under curve
time to maximum concentration

Additional relevant MeSH terms:
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