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This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.
This study is a randomized, evaluator-blind, single dose, three-arm, crossover, PK study, to be conducted in ~18 healthy, male and female, adult volunteers. PK will be studied at two dose strengths (Arm T1 and Arm T2). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C).
At the Screening Visit and the beginning of each Study Visit, each subject will be trained on the correct self-administration of MDI. The following three randomized treatments will be self-administered, at three Study Visits:
PK blood samples will be taken from a vein at scheduled time points.
Safety parameters and adverse drug events, if any, will be monitored and documented at each study visit. An End-of-Study (EOS) safety evaluation will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment C | Active Comparator | Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose. |
|
| Treatment 1 | Experimental | T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation |
|
| Treatment 2 | Experimental | HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epinephrine inhalation aerosol | Drug | Single dose 220 mcg/inhalation, 10 inhalations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point. | 0 to 30 minutes prior to dosing |
| Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule. | Pre-dose to 6 hours post-dose |
| Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period. | Pre-dose to 6 hours post-dose |
| Time to Reach Peak Concentration (Tmax) for Total Epinephrine | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Vital Signs: Systolic Blood Pressure (SBP) | Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. | Pre-dose (baseline) to 360 minutes post-dose |
| Vital Signs: Diastolic Blood Pressure (DBP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Amphastar Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphastar Location 1 | Cypress | California | 90630 | United States |
A total of 38 subjects were screened, 24 subjects passed screening, consented and were randomized for participation in the study. The IRB approval date was 04/29/2010, the last subject was screened on 05/27/2010.
Participants were recruited from a specialty clinic in Cypress, CA between 04/29/2010 and 05/27/2010
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| ID | Title | Description |
|---|---|---|
| FG000 | C, T1, T2 | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min. |
| FG001 | C, T2, T1 | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min. |
| FG002 | T1, C, T2 | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min. |
| FG003 | T1, T2, C | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min. |
| FG004 | T2, C, T1 | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min. |
| FG005 | T2, T1, C | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 |
| |||||||||||||
| 3-14 Day Washout |
| |||||||||||||
| Visit 2 |
| |||||||||||||
| 3-14 Day Washout |
| |||||||||||||
| Visit 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | C, T1, T2 | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point. | Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period. | Posted | Mean | Standard Deviation | pg/mL | 0 to 30 minutes prior to dosing |
|
All patients were closely monitored for any incidence of adverse events by the investigators during the entire study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment T1 | T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen A. Campbell, Esq. | Amphastar Pharmaceuticals, Inc. | (909) 980-9484 | 2016 | stephenc@amphastar.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| epinephrine inhalation aerosol | Drug | HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations |
|
|
| epinephrine inhalation aerosol | Drug | HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations |
|
|
| Pre-dose to 6 hours post-dose |
| Half-life (t1/2) for Total Epinephrine | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period. | Pre-dose to 6 hours post-dose |
| Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. | Pre-dose to 6 hours post-dose |
Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. |
| Pre-dose (baseline) to 360 minutes post-dose |
| Vital Signs: Heart Rate (HR) | Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. | Pre-dose (baseline) to 360 minutes post-dose |
| ECG: QT Interval | Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. | Pre-dose (baseline) to 360 minutes post-dose |
| ECG: QTc Interval | Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. | Pre-dose (baseline) to 360 minutes post-dose |
| Serum Glucose Levels | Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose. | Pre-dose (baseline) to 360 minutes post-dose |
| Serum Potassium Levels | Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose. | Pre-dose (baseline) to 360 minutes post-dose |
| Hand Tremor Scores | Subjects evaluated hand tremor experiences using a scale from 0 to 3 (0: No tremor; 1: Mild, perceivable; 2: Moderate, observable; and 3: Severe, interfering with hand activities). Hand tremors were evaluated prior to study drug dosing (baseline) and up to 360 minutes post-dose. | Pre-dose (baseline) to 360 minutes post-dose |
| Number of Subjects With Significant Changes in Physical Examination | Physical examinations were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS physical examination compared to the Screening Visit. | Approximately 6 weeks |
| Number of Subjects With Significant Changes in Laboratory Tests | Laboratory tests (CBC, serum comprehensive metabolic panel, urinalysis, and urinary pregnancy test for women of childbearing potential) were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS laboratory tests compared to the Screening Visit. | Approximately 6 weeks |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | C, T2, T1 | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min. |
| BG002 | T1, C, T2 | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min. |
| BG003 | T1, T2, C | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min. |
| BG004 | T2, C, T1 | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min. |
| BG005 | T2, T1, C | Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
| OG001 | Treatment T2 | Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine |
| OG002 | Treatment C | Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine |
|
|
| Primary | Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule. | Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period. | Posted | Mean | Standard Deviation | pg*min/mL | Pre-dose to 6 hours post-dose |
|
|
|
| Primary | Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period. | Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period. | Posted | Mean | Standard Deviation | pg/mL | Pre-dose to 6 hours post-dose |
|
|
|
| Primary | Time to Reach Peak Concentration (Tmax) for Total Epinephrine | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period. | Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period. | Posted | Mean | Standard Deviation | min | Pre-dose to 6 hours post-dose |
|
|
|
| Primary | Half-life (t1/2) for Total Epinephrine | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period. | Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 min post-dose available; and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period. | Posted | Mean | Full Range | min | Pre-dose to 6 hours post-dose |
|
|
|
| Primary | Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose | Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. | Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 minutes post-dose available and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period. | Posted | Mean | Standard Deviation | pg/mL | Pre-dose to 6 hours post-dose |
|
|
|
| Secondary | Vital Signs: Systolic Blood Pressure (SBP) | Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. | Subjects who have taken any amount of study drug treatment. | Posted | Mean | Standard Deviation | mmHg | Pre-dose (baseline) to 360 minutes post-dose |
|
|
|
| Secondary | Vital Signs: Diastolic Blood Pressure (DBP) | Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. | Subjects who have taken any amount of study drug treatment. | Posted | Mean | Standard Deviation | mmHg | Pre-dose (baseline) to 360 minutes post-dose |
|
|
|
| Secondary | Vital Signs: Heart Rate (HR) | Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. | Subjects who have taken any amount of study drug treatment. | Posted | Mean | Standard Deviation | beats per minute | Pre-dose (baseline) to 360 minutes post-dose |
|
|
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| Secondary | ECG: QT Interval | Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. | Subjects who have taken any amount of study drug treatment. | Posted | Mean | Standard Deviation | msec | Pre-dose (baseline) to 360 minutes post-dose |
|
|
|
| Secondary | ECG: QTc Interval | Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. | Subjects who have taken any amount of study drug treatment. | Posted | Mean | Standard Deviation | msec | Pre-dose (baseline) to 360 minutes post-dose |
|
|
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| Secondary | Serum Glucose Levels | Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose. | Subjects who have taken any amount of study drug treatment. | Posted | Mean | Standard Deviation | mg/dL | Pre-dose (baseline) to 360 minutes post-dose |
|
|
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| Secondary | Serum Potassium Levels | Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose. | Subjects who have taken any amount of study drug treatment. | Posted | Mean | Standard Deviation | mmol/L | Pre-dose (baseline) to 360 minutes post-dose |
|
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| Secondary | Hand Tremor Scores | Subjects evaluated hand tremor experiences using a scale from 0 to 3 (0: No tremor; 1: Mild, perceivable; 2: Moderate, observable; and 3: Severe, interfering with hand activities). Hand tremors were evaluated prior to study drug dosing (baseline) and up to 360 minutes post-dose. | Subjects who have taken any amount of study drug treatment. | Posted | Mean | Standard Deviation | score on a scale | Pre-dose (baseline) to 360 minutes post-dose |
|
|
|
| Secondary | Number of Subjects With Significant Changes in Physical Examination | Physical examinations were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS physical examination compared to the Screening Visit. | Subjects who have taken any amount of study drug treatment. The Arm/Group is presented as one group because subjects would have received all 3 different study drug treatments prior to EOS due to the crossover study design. | Posted | Count of Participants | Participants | No | Approximately 6 weeks |
|
|
|
| Secondary | Number of Subjects With Significant Changes in Laboratory Tests | Laboratory tests (CBC, serum comprehensive metabolic panel, urinalysis, and urinary pregnancy test for women of childbearing potential) were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS laboratory tests compared to the Screening Visit. | Subjects who have taken any amount of study drug treatment. The Arm/Group is presented as one group because subjects would have received all 3 different study drug treatments prior to EOS due to the crossover study design. | Posted | Count of Participants | Participants | No | Approximately 6 weeks |
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| EG001 | Treatment T2 | HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations | 0 | 23 | 1 | 23 |
| EG002 | Treatment C | Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose. epinephrine inhalation aerosol : Single dose 220 mcg/inhalation, 10 inhalations | 0 | 22 | 1 | 22 |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Sore throat | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
The PI is to maintain all information, data, inventions and discoveries disclosed by the Sponsor in confidence unless that information was in public domain at time of disclosure or becomes part of the public domain or is published through no fault of the PI or Institution, or was in the possession of the PI or Institution at time of disclosure and was not acquired from Sponsor under any obligation of confidentiality or is produced pursuant to a validly issued subpoena.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Total Epinephrine, 15 min post-dose |
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| Total Epinephrine, 30 min post-dose |
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| Total Epinephrine, 45 min post-dose |
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| Total Epinephrine, 60 min post-dose |
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| Total Epinephrine, 90 min post-dose |
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| Total Epinephrine, 120 min post-dose |
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| Total Epinephrine, 180 min post-dose |
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| Total Epinephrine, 240 min post-dose |
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| Total Epinephrine, 360 min post-dose |
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|
| 30 min post-dose |
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| 60 min post-dose |
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| 120 min post-dose |
|
| 180 min post-dose |
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| 360 min post-dose |
|
|
| 30 min post-dose |
|
| 60 min post-dose |
|
| 120 min post-dose |
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| 180 min post-dose |
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| 360 min post-dose |
|
|
| 30 min post-dose |
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| 60 min post-dose |
|
| 120 min post-dose |
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| 180 min post-dose |
|
| 360 min post-dose |
|
|
| 90 min post-dose |
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| 360 min post-dose |
|
|
| 90 min post-dose |
|
| 360 min post-dose |
|
|
| 30 min post-dose |
|
| 60 min post-dose |
|
| 120 min post-dose |
|
| 360 min post-dose |
|
|
| 30 min post-dose |
|
| 60 min post-dose |
|
| 120 min post-dose |
|
| 360 min post-dose |
|
|
| 60 min post-dose |
|
| 360 min post-dose |
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