Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS
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ClinicalTrials.gov Identifier: NCT01255709 |
Recruitment Status :
Completed
First Posted : December 7, 2010
Last Update Posted : March 17, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Arm T1: Primatene Mist HFA Drug: Arm T2: Primatene Mist HFA Drug: Arm C: Primatene Mist (epinephrine inhalation aerosol, USP) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm T1 Primatene Mist HFA
epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes
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Drug: Arm T1: Primatene Mist HFA
epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes
Other Name: epinephrine inhalation aerosol |
Active Comparator: Arm C Primatene Mist
epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes
|
Drug: Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)
epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes
Other Name: epinephrine inhalation aerosol |
Experimental: Arm T2 Primatene Mist HFA
epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes
|
Drug: Arm T2: Primatene Mist HFA
epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes
Other Name: epinephrine inhalation aerosol |
- Pharmacokinetics including maximum concentration and area under the curve [ Time Frame: -30, 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 min postdose. ]
Samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 0.02 ng/mL, for both epinephrine-d3 and epinephrine-h3.
- Mean Maximum concentration of epinephrine (Cmax for epinephrine)
- Mean Area Under the Curve (AUC) for epinephrine
- Time to maximum concentration (tmax) and Half life of the drug (t1/2)
- Epinephrine concentrations versus time
- Vital Signs [ Time Frame: within 30 min predose, at 30, 60 and 360 min postdose ]Systolic and Diastolic Blood pressure and heart rate
- 12-lead Electrocardiogram (ECG) [ Time Frame: within 30 min pre-dose, and at 15 and 120 min post-dose ]12 lead ECG (Routine and QT/QTc intervals)
- Telemetry ECG [ Time Frame: within 30 min pre-dose, and during the initial 5 min post-dose ]Telemetry recording of heart rate

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Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Generally healthy at screening;
- Body weight ≥ 50 kg for men and ≥ 45 kg for women;
- Sitting blood pressure ≤ 135/90 mmHg;
- Demonstrating negative hIV, HBsAG and DCV-Ab screen tests;
- Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
- Properly consented
- Other criteria apply
Exclusion Criteria:
- A smoking history of ≥10 pack-years, or having smoked within 6 months prior to Screening;
- Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
- Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs;
- Known intolerance or hypersensitivity to the study MDI ingredients;
- Having been on other investigational drug/device studies, or donated blood, in the last 30 days prior to Screening;
- Other criteria apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255709
United States, California | |
Amphastar Study Site 1 | |
Cypress, California, United States, 90630 |
Study Director: | Medical Director | Amphastar Pharmaceuticals, Inc. |
Responsible Party: | Amphastar Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01255709 |
Other Study ID Numbers: |
API-E004-CL-B3 |
First Posted: | December 7, 2010 Key Record Dates |
Last Update Posted: | March 17, 2016 |
Last Verified: | February 2016 |
Asthma shortness of breath wheezing |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Epinephrine Racepinephrine Epinephryl borate Adrenergic alpha-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents |