Clinical Trial: A Pilot Study of the Bioavailability of Nasal Naloxone

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study of the Bioavailability of Nasal Naloxone

Brief Summary:

The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters:

  • Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers
  • Preliminary estimation of the maximum serum concentration (Cmax) of this formulation
  • Preliminary estimation of the time to maximum serum concentration (Tmax) of this formulation
  • Safety of the formulation

Detailed Summary:
Sponsor: Norwegian University of Science and Technology

Current Primary Outcome: preliminary bioavailability of nasal naloxone [ Time Frame: 2 weeks ]

measured as ratio of area under the time concentration curve for nasal over intravenous naloxone x 100. Plasma concentration data will be analyzed by non-compartmental techniques.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • time to maximum concentrations [ Time Frame: 2 weeks ]
  • maximum concentration [ Time Frame: 2 weeks ]


Original Secondary Outcome: Same as current

Information By: Norwegian University of Science and Technology

Dates:
Date Received: September 2, 2013
Date Started: August 2013
Date Completion:
Last Updated: January 2, 2015
Last Verified: January 2015