A Pilot Study of the Bioavailability of Nasal Naloxone

A Pilot Study of the Bioavailability of Nasal Naloxone

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

Inclusion Criteria:

• healthy (adequate organ function is determined by electrocardiogram (ECG), liver and kidney clinical chemistry, and a standard clinical examination/interview. For safety reasons we may ask for urine sample for analysis of opioids)
• informed consent

Exclusion Criteria:

• history of liver disease
• taking any medications including herbal medicines the last week history of drug abuse
• any local nasal disease or nasal surgery or recent cold for the last week
• any history of drug allergies