| Primary | First Timepoint When There is a Higher Naloxone Plasma Concentration in the 4 Naloxone Dose Arm (1 Every 2.5 Min) Compared to the 2 Naloxone Dose Arm (1 Every 2.5 Min) | Naloxone plasma concentrations will be determined at specified timepoints. The four naloxone nasal spray dose arm (1 dose every 2.5 min) will be compared separately to the two naloxone nasal spray dose arm (1 dose every 2.5 min). | Includes any participant who had naloxone plasma concentration samples available within the specified PK sampling window and who did not miss one of the assigned doses. Prespecified timepoints for comparison were 10, 12.5, and 15 minutes. Only the data for the first timepoint when there is a higher naloxone plasma concentration in the 4 naloxone dose arm was prespecified for reporting. 10-minute data is shown. below | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10, 12.5, and 15 minutes, 10 minutes reported | | | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min | | OG001 | C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) Two naloxone nasal spray doses (1 every 2.5 min): Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0008.49± 70
- OG0014.42± 159
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Up to three different time points have been pre-specified for the comparison (10, 12.5, and 15 min). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm. | t-test, 1 sided | | 0.002 | Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected. | Geometric mean ratio | 1.95 | | | 1-Sided | 95.6 | 1.28 | | | | |
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| Primary | First Timepoint When There is a Higher Naloxone Plasma Concentration in the 4 Naloxone Dose Arm (2 Doses Every 2.5 Min) Compared to the 2 Naloxone Dose Arm (1 Every 2.5 Min) | Naloxone plasma concentrations will be determined at specified timepoints. The four naloxone nasal spray dose arm (2 doses every 2.5 min) will be compared separately to the two naloxone nasal spray dose arm (1 dose every 2.5 min). | Includes any participant who had naloxone plasma concentration samples available within the specified PK sampling window and who did not miss one of the assigned doses. Prespecified timepoints for comparison were 4.5, 7, and 10 minutes. Only the data for the first timepoint when there is a higher naloxone plasma concentration in the 4 naloxone dose arm (2 doses every 2.5 min) was prespecified for reporting. 4.5-minute data is shown. below | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 4.5, 7, and 10 minutes | | | | ID | Title | Description |
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| OG000 | B. Four Naloxone Nasal Spray Doses (2 Every 2.5 Min) | Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) Four naloxone nasal spray doses (2 every 2.5 min): Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) | | OG001 | C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) Two naloxone nasal spray doses (1 every 2.5 min): Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) |
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| Secondary | First Timepoint When There is a Higher Naloxone Plasma Concentration in the 4 Naloxone Dose Arm B (2 Doses Every 2.5 Min) Compared to the 4 Naloxone Dose Arm A (1 Dose Every 2.5 Minutes) | Naloxone plasma concentrations will be determined at specified timepoints. The 4 naloxone dose arm B (2 doses every 2.5 min) will be compared to the 4 naloxone dose arm A (1 dose every 2.5 min) | Includes any participant who had naloxone plasma concentration samples available within the specified PK sampling window and who did not miss one of the assigned doses. Prespecified timepoints for comparison were 4.5, 7, and 10 minutes. Only the data for the first timepoint when there is a higher naloxone plasma concentration in the 4 naloxone dose arm (2 every 2.5 min) was prespecified for reporting. 4.5-minute data is shown. below | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 4.5, 7, and 10 minutes | | | | ID | Title | Description |
|---|
| OG000 | B. Four Naloxone Nasal Spray Doses (2 Every 2.5 Min) | Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) Four naloxone nasal spray doses (2 every 2.5 min): Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) | | OG001 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min |
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| Secondary | Dose-proportionality of the 4 Naloxone Dose Arms in Reference to the 2 Naloxone Dose Arm Based on Maximum Concentration (Cmax). | Dose proportionality based on Cmax will be compared between each of the three IN naloxone treatments as a secondary endpoint. For the comparisons, the 4 naloxone dose arms will be considered as the test and the reference will be the 2 naloxone dose arm. An additional comparison will be performed between the 4 naloxone dose arm B (2 doses every 2.5 min) as test and the 4 naloxone dose arm A (1 dose every 2.5 min) as reference. Values are reported as dose-normalized Cmax. | Includes any participant who receive study drug and have at least one post-dose sample collected. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL / mg (dose) | | 0 [pre-dose], 2, 4.5, 7, 10, 12.5, 15, 20, 30, 45, 60, 120, 180, 240, 360, and 720 minutes | | | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min | | OG001 | B. Four Naloxone Nasal Spray Doses (2 Every 2.5 Min) | Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) Four naloxone nasal spray doses (2 every 2.5 min): Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) |
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| Secondary | Dose-proportionality of the 4 Naloxone Dose Arms in Reference to the 2 Naloxone Dose Arm Based on Area Under the Curve From Time 0 to Infinity (AUC0-inf) | Dose proportionality based on AUC0-inf will be compared between each of the three IN naloxone treatments as a secondary endpoint. For the comparisons, the 4 naloxone dose arms will be considered as the test and the reference will be the 2 naloxone dose arm. An additional comparison will be performed between the 4 naloxone dose arm B (2 doses every 2.5 min) as test and the 4 naloxone dose arm A (1 dose every 2.5 min) as reference. Values are reported as dose-normalized AUC0-inf. | Includes any participant who received study drug and had at least one post-dose sample collected. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL * hr / mg (dose) | | 0 [pre-dose], 2, 4.5, 7, 10, 12.5, 15, 20, 30, 45, 60, 120, 180, 240, 360, and 720 minutes | | | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min | | OG001 | B. Four Naloxone Nasal Spray Doses (2 Every 2.5 Min) | Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) Four naloxone nasal spray doses (2 every 2.5 min): Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) |
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| Secondary | Dose-proportionality of the 4 Naloxone Dose Arms in Reference to the 2 Naloxone Dose Arm Based on Area Under the Curve From Time 0 to Last Sample (AUC0-t) | Dose proportionality based on AUC0-t will be compared between each of the three IN naloxone treatments as a secondary endpoint. For the comparisons, the 4 naloxone dose arms will be considered as the test and the reference will be the 2 naloxone dose arm. An additional comparison will be performed between the 4 naloxone dose arm B (2 doses every 2.5 min) as test and the 4 naloxone dose arm A (1 dose every 2.5 min) as reference. Values are reported as dose-normalized AUC0-t. | Includes any participant who received study drug and had at least one post-dose sample collected. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL * hr / mg (dose) | | 0 [pre-dose], 2, 4.5, 7, 10, 12.5, 15, 20, 30, 45, 60, 120, 180, 240, 360, and 720 minutes | | | | ID | Title | Description |
|---|
| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min | | OG001 | B. Four Naloxone Nasal Spray Doses (2 Every 2.5 Min) | Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) Four naloxone nasal spray doses (2 every 2.5 min): Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) |
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| Secondary | Predicted Time to Rescue a Patient From Simulated Opioid-induced Respiratory Depression From Fentanyl for a Medium Overdose Scenario | Data from this study will be combined with an existing pharmacokinetic/pharmacodynamic (PK/PD) model for opioid-induced respiratory depression to determine mean time to rescue. An intravenous fentanyl dose of 1.63 mg was selected as representative of a medium overdose scenario. The first naloxone dose in the simulations was administered 1 minute after ventilation decreased to 40% of baseline. Brain hypoxia (time to rescue a simulated patient) was defined as time brain oxygen partial pressure was less than 20 mm Hg and cardiac arrest was defined as the time cardiac output was less than 0.01 L/min. A value of 120 minutes means that simulated patients for that measure/dispersion metric were not predicted to recovered for the opioid dose and intervention. | Simulated patient data are reported as median and interquartile range (IQR) based on 200 randomly selected simulated patients from a population of 2000 with different pharmacokinetic and binding parameters and repeating this 2500 times with replacement. Reported result is the median and interquartile range from 2500 simulated studies with 200 simulated patients each. | Posted | | Median | Inter-Quartile Range | min | | 720 minutes | Number of Simulations | Number of Simulations | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min |
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| Secondary | Predicted Time to Rescue a Patient From Simulated Opioid-induced Respiratory Depression From Fentanyl for a High Overdose Scenario | Data from this study will be combined with an existing pharmacokinetic/pharmacodynamic (PK/PD) model for opioid-induced respiratory depression to determine mean time to rescue. An intravenous fentanyl dose of 2.97 mg was selected as representative of a medium overdose scenario. The first naloxone dose in the simulations was administered 1 minute after ventilation decreased to 40% of baseline. Brain hypoxia (time to rescue a simulated patient) was defined as time brain oxygen partial pressure was less than 20 mm Hg and cardiac arrest was defined as the time cardiac output was less than 0.01 L/min. A value of 120 minutes means that simulated patients for that measure/dispersion metric were not predicted to recovered for the opioid dose and intervention. | Simulated patient data are reported as median and interquartile range (IQR) based on 200 randomly selected simulated patients from a population of 2000 with different pharmacokinetic and binding parameters and repeating this 2500 times with replacement. Reported result is the median and interquartile range from 2500 simulated studies with 200 simulated patients each. | Posted | | Median | Inter-Quartile Range | min | | 720 minutes | Number of Simulations | Number of Simulations | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min |
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| Secondary | Predicted Time to Rescue a Patient From Simulated Opioid-induced Respiratory Depression From Carfentanil for a Medium Overdose Scenario | Data from this study will be combined with an existing pharmacokinetic/pharmacodynamic (PK/PD) model for opioid-induced respiratory depression to determine mean time to rescue. An intravenous carfentanil dose of 0.012 mg was selected as representative of a medium overdose scenario. The first naloxone dose in the simulations was administered 1 minute after ventilation decreased to 40% of baseline. Brain hypoxia (time to rescue a simulated patient) was defined as time brain oxygen partial pressure was less than 20 mm Hg and cardiac arrest was defined as the time cardiac output was less than 0.01 L/min. A value of 120 minutes means that simulated patients for that measure/dispersion metric were not predicted to recovered for the opioid dose and intervention. | Simulated patient data are reported as median and interquartile range (IQR) based on 200 randomly selected simulated patients from a population of 2000 with different pharmacokinetic and binding parameters and repeating this 2500 times with replacement. Reported result is the median and interquartile range from 2500 simulated studies with 200 simulated patients each. | Posted | | Median | Inter-Quartile Range | min | | 720 min | Number of Simulations | Number of Simulations | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min |
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| Secondary | Predicted Time to Rescue a Patient From Simulated Opioid-induced Respiratory Depression From Carfentanil for a High Overdose Scenario | Data from this study will be combined with an existing pharmacokinetic/pharmacodynamic (PK/PD) model for opioid-induced respiratory depression to determine mean time to rescue. An intravenous carfentanil dose of 0.022 mg was selected as representative of a medium overdose scenario. The first naloxone dose in the simulations was administered 1 minute after ventilation decreased to 40% of baseline. Brain hypoxia (time to rescue a simulated patient) was defined as time brain oxygen partial pressure was less than 20 mm Hg and cardiac arrest was defined as the time cardiac output was less than 0.01 L/min. A value of 120 minutes means that simulated patients for that measure/dispersion metric were not predicted to recovered for the opioid dose and intervention. | Simulated patient data are reported as median and interquartile range (IQR) based on 200 randomly selected simulated patients from a population of 2000 with different pharmacokinetic and binding parameters and repeating this 2500 times with replacement. Reported result is the median and interquartile range from 2500 simulated studies with 200 simulated patients each. | Posted | | Median | Inter-Quartile Range | min | | 720 min | Number of Simulations | Number of Simulations | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min |
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| Other Pre-specified | Naloxone Cmax | PK parameter for Cmax will be calculated | Includes any participant who received study drug and had at least one post-dose sample collected. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 0 [pre-dose], 2, 4.5, 7, 10, 12.5, 15, 20, 30, 45, 60, 120, 180, 240, 360, and 720 minutes | | | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min | | OG001 | B. Four Naloxone Nasal Spray Doses (2 Every 2.5 Min) | Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) Four naloxone nasal spray doses (2 every 2.5 min): Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) | | OG002 | C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) Two naloxone nasal spray doses (1 every 2.5 min): Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) |
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| Other Pre-specified | Naloxone AUC0-inf | PK parameter AUC0-inf for naloxone will be calculated | Includes any participant who received study drug and had at least one post-dose sample collected. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL * hr | | 0 [pre-dose], 2, 4.5, 7, 10, 12.5, 15, 20, 30, 45, 60, 120, 180, 240, 360, and 720 minutes | | | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min | | OG001 | B. Four Naloxone Nasal Spray Doses (2 Every 2.5 Min) | Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) Four naloxone nasal spray doses (2 every 2.5 min): Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) | | OG002 | C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) Two naloxone nasal spray doses (1 every 2.5 min): Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) |
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| Other Pre-specified | Naloxone AUC0-t | PK parameter AUC0-t for naloxone will be calculated | Includes any participant who received study drug and had at least one post-dose sample collected. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL * hr | | 0 [pre-dose], 2, 4.5, 7, 10, 12.5, 15, 20, 30, 45, 60, 120, 180, 240, 360, and 720 minutes | | | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min | | OG001 | B. Four Naloxone Nasal Spray Doses (2 Every 2.5 Min) | Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) Four naloxone nasal spray doses (2 every 2.5 min): Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) | | OG002 | C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) Two naloxone nasal spray doses (1 every 2.5 min): Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) |
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| Other Pre-specified | Naloxone Time of Maximum Concentration (Tmax) | PK parameter tmax for naloxone will be calculated | Includes any participant who received study drug and had at least one post-dose sample collected. | Posted | | Median | Inter-Quartile Range | min | | 0 [pre-dose], 2, 4.5, 7, 10, 12.5, 15, 20, 30, 45, 60, 120, 180, 240, 360, and 720 minutes | | | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min | | OG001 | B. Four Naloxone Nasal Spray Doses (2 Every 2.5 Min) | Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) Four naloxone nasal spray doses (2 every 2.5 min): Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) | | OG002 | C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) Two naloxone nasal spray doses (1 every 2.5 min): Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min) |
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| Other Pre-specified | Naloxone Partial Area Under the Curve (pAUC) From First Dose to 30 Minutes | PK parameter pAUC from time 0 to 30 minutes for naloxone will be calculated | Includes any participant who received study drug and had at least one post-dose sample collected. Partial AUCs are reported for 0 minutes to 7 minutes, 0 minutes to 10 minutes, 0 minutes to 12.5 minutes, 0 minutes to 15 minutes, 0 minutes to 20 minutes, and 0 minutes to 30 minute. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL * hr | | 0 [pre-dose], 2, 4.5, 7, 10, 12.5, 15, 20, and 30 minutes | | | | ID | Title | Description |
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| OG000 | A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min) | Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min) Four naloxone nasal spray doses (1 every 2.5 min): Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min | | OG001 | B. Four Naloxone Nasal Spray Doses (2 Every 2.5 Min) | Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) Four naloxone nasal spray doses (2 every 2.5 min): Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min) | | OG002 | C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min) |
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