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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants received naloxone nasal spray following a 10 hour fast.
Participants received naloxone nasal spray following a 10 hour fast.
Participants received naloxone HCl IM injection following a 10 hour fast.
Worldwide Clinical Trials
San Antonio, Texas, United States
Plasma Concentration of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 1 hour post-dose
Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 1 hour post-dose
Area Under the Curve from Time 0 to the Last Measured Concentration (AUC0-t) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Area Under the Curve from Time 0 to Infinity (AUC0-inf) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Percentage of AUC0-inf Obtained by Extrapolation (AUCextrap) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Last Quantifiable Concentration (Clast) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Time of the Last Quantifiable Concentration (Tlast) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
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Time Prior to the First Measurable (Non-Zero) Concentration (Tlag) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Rate Constant (λz) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Half-Life (t1/2) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Day 1 up to Day 10