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Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01761565
First received: January 3, 2013
Last updated: October 4, 2013
Last verified: January 2013
  Purpose

determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs


Condition Intervention Phase
Plasma Concentrations
Drug: Sufentanil
Phase 1

Study Type: Interventional
Official Title: Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • plasma concentration [ Time Frame: 24 hours ]

Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sufentanil NanoTab Single Dose Drug: Sufentanil
Experimental: Sufentanil NanoTab Multiple Dose Drug: Sufentanil

  Eligibility

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

Inclusion Criteria:

  • non smokers

Exclusion Criteria:

  • pregnant or breastfeeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761565

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: NCT01761565     History of Changes
Other Study ID Numbers: IAP101
Study First Received: January 3, 2013
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014