A Phase 4 interventional study of Epinephrine (0.125 mg/inhalation) and Epinephrine Injection Auto-Injector (0.3mg/0.3mL) in Pharmacokinetics, Epinephrine and Albuterol, sponsored by Amphastar Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by Amphastar Pharmaceuticals, Inc. · Phase 4, Interventional, and Treatment
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 28 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Amphastar Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who dosed with Primatene Mist.
Combination Product: Epinephrine (0.125 mg/inhalation)
Participants who were dosed with an Epinephrine Injection Auto-Injector.
Combination Product: Epinephrine Injection Auto-Injector (0.3mg/0.3mL)
Participants who dosed with Albuterol HFA.
Combination Product: Albuterol Sulfate (0.09 mg/inhalation)
Drug page: Epinephrine
Participants will self-administer 2 inhalations of Epinephrine (0.125 mg/inhalation) for a total dosage of 0.25 mg.
Also known as: Primatene Mist
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.
Also known as: Generic of EpiPen
Drug page: Albuterol
Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg.
Also known as: Albuterol HFA
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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[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.
Time frame: 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.
Time frame: 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.
| Milestone | A-B-C | B-C-A | C-A-B |
|---|---|---|---|
| Started | 9 | 10 | 9 |
| Completed | 9 | 10 | 9 |
| Not completed | 0 | 0 | 0 |
| Milestone | A-B-C | B-C-A | C-A-B |
|---|---|---|---|
| Started | 9 | 10 | 9 |
| Completed | 9 | 10 | 8 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Milestone | A-B-C | B-C-A | C-A-B |
|---|---|---|---|
| Started | 9 | 10 | 8 |
| Completed | 9 | 10 | 8 |
| Not completed | 0 | 0 | 0 |
| Milestone | A-B-C | B-C-A | C-A-B |
|---|---|---|---|
| Started | 9 | 10 | 8 |
| Completed | 9 | 10 | 7 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Milestone | A-B-C | B-C-A | C-A-B |
|---|---|---|---|
| Started | 9 | 10 | 7 |
| Completed | 9 | 10 | 7 |
| Not completed | 0 | 0 | 0 |
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.
| pg/mL | Primatene Mist, E004 | Epinephrine Injection Auto-Injector (Generic of EpiPen) | Albuterol HFA |
|---|---|---|---|
| C[Max], Maximum Plasma Concentration of Albuterol or Epinephrine | 240.8 ± 2.4 | 704.8 ± 1.8 | 599.8 ± 1.7 |
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.
| pg/mL x hr | Primatene Mist, E004 | Epinephrine Injection Auto-Injector (Generic of EpiPen) | Albuterol HFA |
|---|---|---|---|
| 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) | 26.8 ± 3.1 | 509.9 ± 1.5 | 3332.3 ± 1.3 |
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.
| pg/mL x hr | Primatene Mist, E004 | Epinephrine Injection Auto-Injector (Generic of EpiPen) | Albuterol HFA |
|---|---|---|---|
| AUC(0-tm)_DE, Area Under the Curve (AUC) of Exogenous Active Product Ingredient (API) From Time 0 to Time (tm) | 18.4 ± 3.6 | 396.3 ± 1.6 | 3332.3 ± 1.3 |
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.
| pg/mL x hr | Primatene Mist, E004 | Epinephrine Injection Auto-Injector (Generic of EpiPen) | Albuterol HFA |
|---|---|---|---|
| AUC(0-inf), Area Under the Curve (AUC) of Albuterol or Epinephrine From Time 0 to Infinity | 18.4 ± 3.6 | 411.4 ± 1.7 | 3650.4 ± 1.3 |
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.
| min | Primatene Mist, E004 | Epinephrine Injection Auto-Injector (Generic of EpiPen) | Albuterol HFA |
|---|---|---|---|
| t[Max], Time at Which Maximum Plasma Concentration of Albuterol or Epinephrine is Observed | 2.6 ± 3.0 | 8.3 ± 2.7 | 21.8 ± 3.1 |
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.
| min | Primatene Mist, E004 | Epinephrine Injection Auto-Injector (Generic of EpiPen) | Albuterol HFA |
|---|---|---|---|
| t[1/2], Terminal Elimination Half-life of Albuterol or Epinephrine | 7.1 ± 5.2 | 138.8 ± 4.0 | 420.7 ± 1.2 |
Collected over From signing of consent until follow-up (approximately 4 weeks). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primatene Mist, E004 | 0/27 (0%) | 0/27 (0%) | 3/27 (11.1%) |
| Epinephrine Injection Auto-Injector (Generic of EpiPen) | 0/26 (0%) | 0/26 (0%) | 1/26 (3.8%) |
| Albuterol HFA | 0/28 (0%) | 0/28 (0%) | 2/28 (7.1%) |
| Event | Primatene Mist, E004 | Epinephrine Injection Auto-Injector (Generic of EpiPen) | Albuterol HFA |
|---|---|---|---|
| HeadacheNervous system disorders | 3/27 | 0/26 | 1/28 |
| Injection Site PainGeneral disorders | 0/27 | 1/26 | 0/28 |
| NasopharyngitisRespiratory, thoracic and mediastinal disorders | 1/27 | 0/26 | 0/28 |
| NauseaGastrointestinal disorders | 0/27 | 0/26 | 1/28 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 37.1 ± 7.6 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 14 |
| Male | 14 |
| Race/Ethnicity, Customized(Participants) | All Study Participants |
|---|---|
| White | 13 |
| Black or African-American | 10 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| American Indian or Alaska Native | 0 |
| Other | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — 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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Studies of the drug tested here: Epinephrine
Amphastar Pharmaceuticals, Inc.