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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Treatment Sequence A-B-C | Experimental | Participants received Treatment A on Day 1 of Period 1, Treatment B on Day 1 of Period 2, and Treatment C on Day 1 of Period 3. |
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| Cohort 2: Treatment Sequence B-C-A | Experimental | Participants received Treatment B on Day 1 of Period 1, Treatment C on Day 1 of Period 2, and Treatment A on Day 1 of Period 3. |
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| Cohort 3: Treatment Sequence C-A-B | Experimental | Participants received Treatment C on Day 1 of Period 1, Treatment A on Day 1 of Period 2, and Treatment B on Day 1 of Period 3. |
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| Cohort 4: Treatment Sequence A-C-B | Experimental | Participants received Treatment A on Day 1 of Period 1, Treatment C on Day 1 of Period 2, and Treatment B on Day 1 of Period 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A: Naloxone Nasal Spray | Drug | Participants received naloxone nasal spray following a 10 hour fast. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Unconjugated Naloxone | Pre-dose and at multiple time points up to 1 hour post-dose | |
| Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone | Pre-dose and at multiple time points up to 1 hour post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from Time 0 to the Last Measured Concentration (AUC0-t) of Unconjugated Naloxone | 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 | Pre-dose and at multiple time points up to 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni DeCastro | INSYS Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | United States |
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| Cohort 5: Treatment Sequence C-B-A | Experimental | Participants received Treatment C on Day 1 of Period 1, Treatment B on Day 1 of Period 2, and Treatment A on Day 1 of Period 3. |
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| Cohort 6: Treatment Sequence B-A-C | Experimental | Participants received Treatment B on Day 1 of Period 1, Treatment A on Day 1 of Period 2, and Treatment C on Day 1 of Period 3. |
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| Treatment B: Naloxone Nasal Spray | Drug | Participants received naloxone nasal spray following a 10 hour fast. |
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| Treatment C: Naloxone HCL Intramuscular (IM) Injection | Drug | Participants received naloxone HCl IM injection following a 10 hour fast. |
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| Percentage of AUC0-inf Obtained by Extrapolation (AUCextrap) of Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Maximum Plasma Concentration (Cmax) of Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Time to Reach Maximum Plasma Concentration (Tmax) of Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Last Quantifiable Concentration (Clast) of Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Time of the Last Quantifiable Concentration (Tlast) of 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) of Unconjugated Naloxone | Pre-dose and at multiple time points up to 24 hours post-dose |
| Elimination Rate Constant (λz) of 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 |
| 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. | Day 1 up to Day 10 |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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