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 ]
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