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Effect of Delivery Route on PK of Sufentanil NanoTab

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ClinicalTrials.gov Identifier: NCT01639729
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : May 21, 2014
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : July 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




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

  2. Cmax [ Time Frame: 24 hours ]
    maximum plasma concentration

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

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



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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

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.

Publications:
Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01639729     History of Changes
Other Study ID Numbers: IAP102
First Posted: July 13, 2012    Key Record Dates
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