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To assess the drug exposure profile in systemic circulation of Primatene Mist by inhalation, versus Epinephrine by intramuscular injection, and ProAir HFA by inhalation in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primatene Mist, E004 | Experimental | Participants who dosed with Primatene Mist. |
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| Epinephrine Injection Auto-Injector (Generic of EpiPen) | Active Comparator | Participants who were dosed with an Epinephrine Injection Auto-Injector. |
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| Albuterol HFA | Active Comparator | Participants who dosed with Albuterol HFA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine (0.125 mg/inhalation) | Combination Product | Participants will self-administer 2 inhalations of Epinephrine (0.125 mg/inhalation) for a total dosage of 0.25 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| C[Max], Maximum Plasma Concentration of Albuterol or Epinephrine | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. C[max] will be obtained directly from the plot of PK curve. | Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
| AUC(0-tm)_TOT, Area Under the Curve (AUC) of Total (Exogenous and Endogenous, if Available) Active Product Ingredient (API) From Time 0 to Time (tm) | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-tm)_TOT will be calculated with the trapezoid method. Time tm is defined as the time after C[max] is reached where API concentration is reduced to the levels of the same day baseline. | Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
| AUC(0-tm)_DE, Area Under the Curve (AUC) of Exogenous Active Product Ingredient (API) From Time 0 to Time (tm) | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-tm)_DE will be calculated with the trapezoid method. Time tm is defined as the time after C[max] is reached where API concentration is reduced to the levels of the same day baseline. | Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
| AUC(0-inf), Area Under the Curve (AUC) of Albuterol or Epinephrine From Time 0 to Infinity | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-inf) will be calculated with the extrapolation method. |
| Measure | Description | Time Frame |
|---|---|---|
| t[Max], Time at Which Maximum Plasma Concentration of Albuterol or Epinephrine is Observed | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. t[max] will be obtained directly from the plot of PK curve when the maximum concentration is observed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphastar Study Site 0035 | Cypress | California | 90630 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39207239 | Derived | Zhang JY, Luo MZ, Marrs T, Kerwin EM, Bukstein DA. Comparison of Systemic Exposure Between Epinephrine Delivered via Metered-Dose Inhalation and Intramuscular Injection. J Aerosol Med Pulm Drug Deliv. 2025 Apr;38(2):71-82. doi: 10.1089/jamp.2024.0025. Epub 2024 Aug 29. |
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Access to patient level data and supporting clinical documents may be requested by qualified researchers. Requests will be reviewed on the basis of scientific merit. Patient data will be de-identified to protect the privacy of trial patients in line with applicable laws and regulations.
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Participants were randomized to receive all 3 treatments over 3 treatment periods in a crossover design.
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| ID | Title | Description |
|---|---|---|
| FG000 | A-B-C | Subjects received one of the three treatments during each study visit. Visit 1: Treatment A: Two (2) inhalations of Primatene Mist (0.125 mg of epinephrine per inhalation), for a total dosage of 0.25 mg; Visit 2: Treatment B: Intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL), for a total dosage of 0.30 mg; Visit 3: Treatment C: Two (2) inhalations of Albuterol HFA (0.09 mg of albuterol sulfate per inhalation), for a total dosage of 0.18 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2019 | Jan 25, 2021 |
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| Epinephrine Injection Auto-Injector (0.3mg/0.3mL) | Combination Product | Participants will receive an intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL). The 0.30 mL dose will be given perpendicularly as a single deep intramuscular injection into the anterolateral aspect of the thigh. |
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| Albuterol Sulfate (0.09 mg/inhalation) | Combination Product | Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg. |
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| Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
| Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
| t[1/2], Terminal Elimination Half-life of Albuterol or Epinephrine | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. | Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
| FG001 | B-C-A | Subjects received one of the three treatments during each study visit. Visit 1: Treatment B: Intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL), for a total dosage of 0.30 mg; Visit 2: Treatment C: Two (2) inhalations of Albuterol HFA (0.09 mg of albuterol sulfate per inhalation), for a total dosage of 0.18 mg; Visit 3: Treatment A: Two (2) inhalations of Primatene Mist (0.125 mg of epinephrine per inhalation), for a total dosage of 0.25 mg. |
| FG002 | C-A-B | Subjects received one of the three treatments during each study visit. Visit 1: Treatment C: Two (2) inhalations of Albuterol HFA (0.09 mg of albuterol sulfate per inhalation), for a total dosage of 0.18 mg; Visit 2: Treatment A: Two (2) inhalations of Primatene Mist (0.125 mg of epinephrine per inhalation), for a total dosage of 0.25 mg; Visit 3: Treatment B: Intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL), for a total dosage of 0.30 mg. |
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| NOT COMPLETED |
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| Washout Period 1 (2-7 Days) |
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| Treatment Period 2 |
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| Washout Period 2 (2-7 Days) |
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| Treatment Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants who have been randomized. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | C[Max], Maximum Plasma Concentration of Albuterol or Epinephrine | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. C[max] will be obtained directly from the plot of PK curve. | Per Protocol Population, defined as all subjects who have received all study medications and are evaluable for all treatments. | Posted | Geometric Mean | Standard Deviation | pg/mL | Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
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| Primary | AUC(0-tm)_TOT, Area Under the Curve (AUC) of Total (Exogenous and Endogenous, if Available) Active Product Ingredient (API) From Time 0 to Time (tm) | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-tm)_TOT will be calculated with the trapezoid method. Time tm is defined as the time after C[max] is reached where API concentration is reduced to the levels of the same day baseline. | Per Protocol Population, defined as all subjects who have received all study medications and are evaluable for all treatments. | Posted | Geometric Mean | Standard Deviation | pg/mL x hr | Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
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| Primary | AUC(0-tm)_DE, Area Under the Curve (AUC) of Exogenous Active Product Ingredient (API) From Time 0 to Time (tm) | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-tm)_DE will be calculated with the trapezoid method. Time tm is defined as the time after C[max] is reached where API concentration is reduced to the levels of the same day baseline. | Per Protocol Population, defined as all subjects who have received all study medications and are evaluable for all treatments. | Posted | Geometric Mean | Standard Deviation | pg/mL x hr | Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
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| Primary | AUC(0-inf), Area Under the Curve (AUC) of Albuterol or Epinephrine From Time 0 to Infinity | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-inf) will be calculated with the extrapolation method. | Per Protocol Population, defined as all subjects who have received all study medications and are evaluable for all treatments. | Posted | Geometric Mean | Standard Deviation | pg/mL x hr | Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
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| Secondary | t[Max], Time at Which Maximum Plasma Concentration of Albuterol or Epinephrine is Observed | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. t[max] will be obtained directly from the plot of PK curve when the maximum concentration is observed. | Per Protocol Population, defined as all subjects who have received all study medications and are evaluable for all treatments. | Posted | Geometric Mean | Standard Deviation | min | Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
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| Secondary | t[1/2], Terminal Elimination Half-life of Albuterol or Epinephrine | Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. | Per Protocol Population, defined as all subjects who have received all study medications and are evaluable for all treatments. | Posted | Geometric Mean | Standard Deviation | min | Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose. |
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From signing of consent until follow-up (approximately 4 weeks)
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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 | Primatene Mist, E004 | Participants who dosed with Primatene Mist. Epinephrine (0.125 mg/inhalation): Participants will self-administer 2 inhalations of Epinephrine (0.125 mg/inhalation) for a total dosage of 0.25 mg. | 0 | 27 | 0 | 27 | 3 | 27 |
| EG001 | Epinephrine Injection Auto-Injector (Generic of EpiPen) | Participants who were dosed with an Epinephrine Injection Auto-Injector. Epinephrine Injection Auto-Injector (0.3mg/0.3mL): Participants will receive an intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL). The 0.30 mL dose will be given perpendicularly as a single deep intramuscular injection into the anterolateral aspect of the thigh. | 0 | 26 | 0 | 26 | 1 | 26 |
| EG002 | Albuterol HFA | Participants who dosed with Albuterol HFA. Albuterol Sulfate (0.09 mg/inhalation): Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg. | 0 | 28 | 0 | 28 | 2 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Injection Site Pain | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amphastar Pharmaceuticals, Inc. | Amphastar Pharmaceuticals, Inc. | (909) 980-9484 | info@amphastar.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2020 | Jan 25, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D000707 | Anaphylaxis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D001239 | Inhalation |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| 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 |
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| American Indian or Alaska Native |
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| Other |
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| OG002 | Albuterol HFA | Participants who dosed with Albuterol HFA. Albuterol Sulfate (0.09 mg/inhalation): Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg. |
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| OG002 | Albuterol HFA | Participants who dosed with Albuterol HFA. Albuterol Sulfate (0.09 mg/inhalation): Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg. |
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| OG002 | Albuterol HFA | Participants who dosed with Albuterol HFA. Albuterol Sulfate (0.09 mg/inhalation): Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg. |
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| OG002 | Albuterol HFA | Participants who dosed with Albuterol HFA. Albuterol Sulfate (0.09 mg/inhalation): Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg. |
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| Albuterol HFA |
Participants who dosed with Albuterol HFA. Albuterol Sulfate (0.09 mg/inhalation): Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg. |
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