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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:2/3/2019
Start Date:April 23, 2018
End Date:May 6, 2018

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A Phase 1, Open-Label, Randomized, Crossover, Comparative Bioavailability Study of Naloxone Nasal Spray and Naloxone Hydrochloride Intravenous and Intramuscular Injection in Healthy Volunteers

The main objective of this study was to compare the bioavailability of two test formulations
of Naloxone Nasal Spray with the reference formulations of Naloxone HCl IV and IM injection
under fasted conditions.


Inclusion Criteria:

- 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

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

- 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
We found this trial at
1
site
San Antonio, Texas 78217
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San Antonio, TX
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