Opioid Overdose | Naloxone Nasal Spray Pharmacokinetic Study
Opioid Overdose research study
What is the primary objective of this study?
This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).
Who is eligible to participate?
Inclusion Criteria: - Male or female - 18-60 50 years of age - Provide written informed consent prior to completing any study specific procedure. - Body Mass Index (BMI) range 18.5-30 kg/m2 - Clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ECG - Using reliable contraception Exclusion Criteria: - Intranasal problems - Taking prescribed or over the counter medications - Intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MVP0052 mg single dose administered intranasally
Drug:MVP0054 mg single dose administered intranasally
Drug:Naloxone hydrochloride solution for injection with mucosal atomization device2 mg single dose administered intranasally
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Test Product Dose 1
Test Product Dose 2
Start Date: June 2012
Completed Date: August 2012
Phase: Phase 1
Primary Outcome: Pharmacokinetics
Secondary Outcome: Number of subjects with adverse events
Study sponsors, principal investigator, and references
Principal Investigator: Abdullah Hiyari, MD
Lead Sponsor: Mitovie Pharma Ltd