A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
INSYS Therapeutics Inc
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
A minimum body weight of 50 kg. Body mass index (BMI) between 18.0 and 32.0 kg/m2
A seated blood pressure between 90 and 140 mmHg systolic/50 and 90 mmHg diastolic
Female subjects had a negative serum β human chorionic gonadotropin (β-hCG) pregnancy test at screening
You may not be if
A known allergy or history of significant adverse reaction to naloxone, other opioids or related compounds, or to any of the excipients
Any documented clinically significant infection, injury, or illness within 1 month prior to screening
An active malignancy of any type, or had been diagnosed with cancer within 5 years prior to screening
A documented history of alcohol or drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within 2 years prior to screening
A positive urine test result for alcohol, drugs, or cotinine at screening or check-in
A condition that the investigator believed would have interfered with the ability to provide informed consent or comply with study instructions, or that could confound the interpretation of the study results or put the subject at undue risk
Used any opioids for 30 days prior to Day 1
Required treatment with monoamine oxidase inhibitors (MAOIs) within 30 days prior to Day 1 and during the study.
Presence of an ongoing upper respiratory infection, rhinitis, rhinorrhea, or nasal congestions
Clareo Health | A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers
