Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose
of naloxone administrated intramuscular and to identify an appropriate intranasal dose that
could achieve systemic exposure comparable to an approved parenteral dose. To also determine
the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to
determine the safety of intranasal naloxone with respect to nasal irritation.