Healthy Volunteer
Conditions
Brief summary
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.
Interventions
Participants received naloxone nasal spray following a 10 hour fast.
Participants received naloxone nasal spray following a 10 hour fast.
DRUGTreatment C: Naloxone HCl Intravenous (IV) Injection
Participants received naloxone HCl IV injection following a 10 hour fast.
DRUGTreatment D: Naloxone HCl Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Sponsors
INSYS Therapeutics Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Elimination Rate Constant (λz) for Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Elimination Half-Life (t1/2) of Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Area Under the Curve From Time 0 to the Last Measured Concentration (AUC0-t) for Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| AUC Extrapolated to Infinity (AUC0-inf) for Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Maximum Plasma Concentration (Cmax) for Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Time to Reach Maximum Plasma Concentration (Tmax) for Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Time Prior to the First Measurable (Non-Zero) Concentration (Tlag) for Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 to Day 14 | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A serious AE (SAE) is any AE that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention. |
| Plasma Concentrations of Unconjugated Naloxone | Pre-dose and at multiple time points up to 2 hours post-dose | — |
Countries
United States
Outcome results
None listed