A Pilot Study of the Bioavailability of Nasal Naloxone

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

Timeline

Start

2013-08

Primary completion

2014-10

Completion

2014-11

Publications

• Results Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Dale O. Naloxone nasal spray - bioavailability and absorption pattern in a phase 1 study. Tidsskr Nor Laegeforen. 2019 Sep 23;139(13). doi: 10.4045/tidsskr.19.0162. Print 2019 Sep 24. English, Norwegian.

Drugs

Indications

No indication recorded.