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Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01721070
First received: November 1, 2012
Last updated: December 7, 2012
Last verified: November 2012
History of Changes
  Purpose

Evaluate the effect of taking ketoconazole sufentanil plasma concentrations following sublingual administration of Sufentanil NanoTab.


Condition Intervention Phase
Pharmacokinetics
 Drug: Sufentanil
 Phase 1

Study Type: Interventional

Resource links provided by NLM:

U.S. FDA Resources

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

Study Start Date: November 2012
Arms Assigned Interventions
Experimental: Sufentanil NanoTab Drug: Sufentanil
Experimental: Sufentanil NanoTab with Ketoconazole 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 smoking

Exclusion Criteria:

  • subjects taking any prescription or OTC medications or vitamins or supplements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721070

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: NCT01721070     History of Changes
Other Study ID Numbers: IAP104
Study First Received: November 1, 2012
Last Updated: December 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ketoconazole
Sufentanil
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 16, 2013