A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers

• Status: Completed
• Trial end date: 2017-08-16
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: INSYS Therapeutics Inc
• Treatments: Naloxone

Criteria

Inclusion Criteria:

• A minimum body weight of 50 kg and a body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m2)

• A seated blood pressure between 90 and 140 millimeters of mercury (mmHg) systolic/50 and 90 mmHg diastolic (inclusive)

• Female subjects had a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening

Exclusion Criteria:

• 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. Alcohol abuse was defined as greater than 14 drinks per week.

• Positive serology test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at 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 congestion.