Effect of Delivery Route on PK of Sufentanil NanoTab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01639729
First received: July 11, 2012
Last updated: November 9, 2012
Last verified: November 2012
  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: Sufentanil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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:
  • Area under the curve [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Arms Assigned Interventions
Active Comparator: sufentanil Drug: Sufentanil
15 mcg IV
Experimental: sufentanil tablet Drug: Sufentanil
15 mcg sublingual
Drug: Sufentanil
15 mcg buccal
Drug: Sufentanil
15 mcg oral

  Eligibility

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

Inclusion Criteria:

  • body mass index 18 - 30

Exclusion Criteria:

  • pregnant females
  • smokers
  • pulmonary disease
  • sleep apnea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639729

Locations
United States, Kansas
PRA
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01639729     History of Changes
Other Study ID Numbers: IAP102
Study First Received: July 11, 2012
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Sufentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on April 16, 2014