AsthmaPhase 1/2NCT01737892
Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
A Phase 1/2 study testing Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation and Arm C-Epinephrine Inhalation Aerosol CFC in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation and Arm C-Epinephrine Inhalation Aerosol CFC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Nov 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy, male and female adults, 18-30 yrs of age at Screening
- Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses, per investigator discretion;
- Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive
- Sitting blood pressure less than or equal to 135/90 mmHg;
- Demonstrating negative alcohol/drug screen tests;
- Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;
- Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
- Having properly consented and satisfied all other inclusion/exclusion criteria as required for this protocol.
Who cannot join
- A smoking history of more than or equal to 10 pack-years, or having smoked within 6 months prior to Screening;
- Upper respiratory tract infections within 2 weeks, or lower respiratory tract infection within 4 weeks, prior to Screening
- Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including but not limited to: asthma, COPD, cystic fibrosis, bronchiectasis, tuberculosis, emphysema, etc.
- Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine (including diabetes), psychiatric, neoplastic or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study
- Known intolerance or hypersensitivity to any of the study MDI ingredients (i.e., epinephrine, HFA-134a, CFC-12, CFC-114, polysorbate-80, ethanol, thymol, nitric acid and ascorbic acid)
- Use of prohibited drugs or failure to observe the drug washout restrictions
- Having been on other investigational drug/device studies, or donated blood, in the last 30 days prior to Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials, LLC
Cypress, California, 90630
About this study
Official title: Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers)
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed to complement an earlier PK study, API-E004-CL-B, for a more thorough evaluation of the E004 PK. Safety of E004 will also be evaluated.
Read the detailed description
This study is a randomized, evaluator-blind, single dose, two-arm, crossover, PK study, to be conducted in ~18 healthy, male and female, adult volunteers. PK will be studied using E004-d3 at 125 mcg per inhalation (Arm T). A previously marketed Epinephrine CFC-MDI, labeled "For Investigational Use Only" will be used as a Reference Control (Arm C).
The main features of the study design are:
(1) All candidates must be screened and must satisfy all enrollment criteria. All enrolled subjects will participate in two Study Visits, corresponding to two randomized treatments. Each Study Visit consists of a pre-dose baseline assessment and a post-dose evaluation for 6 hours.
(2) It is important to minimize physical and psychological disturbances to the endogenous epinephrine concentrations in the study subjects, before and during the study visits. All subjects must maintain a reclining or recumbent resting position during the entire Study Visit, with physical activities restricted to a minimum necessity for bathroom trips and study activities. Caffeine-containing (including de-caffeinated) foods or beverages are prohibited. Physical exercise, unnecessary physical activities, and video games are prohibited throughout the study visit.
(3)At the Screening Visit and the beginning of each Study Visit, each subject will be trained on the correct self-administration of MDI, using a simulation MDI unit that contains no active drug. The following two randomized treatments will be self-administered at two Study Visits:
Treatment T: Two (2) inhalations of E004-d3 (125 mcg/inhalation), totaling 250 mcg of epinephrine-d3;
Treatment C: Two (2) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation, totaling 440 mcg of epinephrine base equivalent).
(4) PK blood samples will be taken from a vein in a hand or arm via an indwelling anticoagulated IV catheter, or by venipunctures, at scheduled time points of predose baseline (within 30 minutes of dosing), and at 2±1, 5±1, 7.5±1, 10±1, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 minutes postdose. The total volume of blood taken per subject shall not exceed 500 mL in any 30-day period. Study visit schedule may be adjusted to avoid overdrawing blood in any 30-day period.
(5) At each PK sampling point, blood samples (~ 5mL), will be collected in ice-chilled potassium-EDTA sample tubes, each containing pre-added 1% (V:V) of a 1.0 M sodium metabisulfite solution as an antioxidant. Sample tubes will be labeled with a sample ID# (consisting of subject ID#, Study Visit#, and sample#). The sample tubes will be kept on ice or refrigerated, and will be centrifuged within 60 minutes of collection. The harvested plasma from each sample tube will be transferred to, and stored in, 2 storage tubes, respectively, and frozen at NMT -20 degrees C until analysis.
(6) PK samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 5 pg/mL, for both epinephrine-d3 (MW=186) and epinephrine (MW=183).
(7) 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 at the end of, or within 7 days after, Study Visit-2.
- Conditions
- Asthma
- Being tested
- Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation, Arm C-Epinephrine Inhalation Aerosol CFC
- Keywords
- Asthma, Pharmacokinetics, Epinephrine, Bronchodilator, Metered dose inhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalationDrug
Epinephrine Inhalation Aerosol HFA, Single dose 125 mcg, 1 inhalation
Arm C-Epinephrine Inhalation Aerosol CFCDrug
Also called Primatene Mist
Epinephrine Inhalation Aerosol - CFC, Single dose 220 mcg, 1 inhalation
| Study group | Role | What they receive |
|---|---|---|
| Arm T-Epinephrine Inhalation Aerosol HFA | Experimental | Experimental arm utilizing Epinephrine HFA-MDI (E004) Receives: Drug: Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation |
| Arm C-Epinephrine Inhalation Aerosol CFC | Active comparator | Active comparator arm utilizing Epinephrine CFC-MDI Receives: Drug: Arm C-Epinephrine Inhalation Aerosol CFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation and Comparison of relative Bioavailability of Epinephrine
Blood PK samples will be collected at each visit for both study arms, then the Area Under the Curve (s) will be calculated for both arms and compared to give relative bioavailability
Measured: up to 30 min predose and at 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 minutes postdose
Secondary outcomes (4)
Vital Signs
Vital signs (SBP/DBP, blood pressure and heart rate) will be documented and summarized
Measured: up to 30 min predose and at 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 minutes postdose
12-lead ECG (Routine and QT/QTc analysis)
A 12-lead ECG (Routine and QT/QTc analysis) will be documented.
Measured: up to 30 min predose and at 5, 10, 15, 20, 30, 60, 120, and 360 minutes postdose
Physical Examinations
Physical examinations will be documented at screening and end of study
Measured: up to 30 min predose and after 360 min post last dose
Lab tests
Lab tests, including CBC, serum comprehensive metabolic panel, urinalysis, and drug/alcohol screens for all subjects and urinary pregnancy test for women of child-bearing potential will be performed and documented
Measured: up to 30 min predose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: unable to validate analytical method
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Evilevitch, M.D., Study director, Amphastar Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737892
- Sponsor's protocol ID
- API-E004-CL-B4
- Status last verified
- Feb 2016
- First submitted
- 20 Nov 2012
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pinnas JL, Schachtel BP, Chen TM, Roseberry HR, Thoden WR. Inhaled epinephrine and oral theophylline-ephedrine in the treatment of asthma. J Clin Pharmacol. 1991 Mar;31(3):243-7. doi: 10.1002/j.1552-4604.1991.tb04969.x.
PubMed 2019665Hendeles L, Marshik PL, Ahrens R, Kifle Y, Shuster J. Response to nonprescription epinephrine inhaler during nocturnal asthma. Ann Allergy Asthma Immunol. 2005 Dec;95(6):530-4. doi: 10.1016/S1081-1206(10)61014-9.
PubMed 16400891Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8. doi: 10.1038/clpt.1986.243.
PubMed 3780129Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 2000 Jun;94 Suppl B:S3-9.
PubMed 10919679Dickinson BD, Altman RD, Deitchman SD, Champion HC. Safety of over-the-counter inhalers for asthma: report of the council on scientific affairs. Chest. 2000 Aug;118(2):522-6. doi: 10.1378/chest.118.2.522.
PubMed 10936150Kushner DJ, Baker A, Dunstall TG. Pharmacological uses and perspectives of heavy water and deuterated compounds. Can J Physiol Pharmacol. 1999 Feb;77(2):79-88.
PubMed 10535697
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers)
- ClinicalTrials.gov ID
- NCT01737892
- Acronym / sponsor ID
- API-E004-CL-B4
- Conditions
- Asthma
- Keywords
- Asthma, Pharmacokinetics, Epinephrine, Bronchodilator, Metered dose inhaler
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to validate analytical method
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed to complement an earlier PK study, API-E004-CL-B, for a more thorough evaluation of the E004 PK. Safety of E004 will also be evaluated.
Detailed description
This study is a randomized, evaluator-blind, single dose, two-arm, crossover, PK study, to be conducted in ~18 healthy, male and female, adult volunteers. PK will be studied using E004-d3 at 125 mcg per inhalation (Arm T). A previously marketed Epinephrine CFC-MDI, labeled "For Investigational Use Only" will be used as a Reference Control (Arm C).
The main features of the study design are:
(1) All candidates must be screened and must satisfy all enrollment criteria. All enrolled subjects will participate in two Study Visits, corresponding to two randomized treatments. Each Study Visit consists of a pre-dose baseline assessment and a post-dose evaluation for 6 hours.
(2) It is important to minimize physical and psychological disturbances to the endogenous epinephrine concentrations in the study subjects, before and during the study visits. All subjects must maintain a reclining or recumbent resting position during the entire Study Visit, with physical activities restricted to a minimum necessity for bathroom trips and study activities. Caffeine-containing (including de-caffeinated) foods or beverages are prohibited. Physical exercise, unnecessary physical activities, and video games are prohibited throughout the study visit.
(3)At the Screening Visit and the beginning of each Study Visit, each subject will be trained on the correct self-administration of MDI, using a simulation MDI unit that contains no active drug. The following two randomized treatments will be self-administered at two Study Visits:
Treatment T: Two (2) inhalations of E004-d3 (125 mcg/inhalation), totaling 250 mcg of epinephrine-d3;
Treatment C: Two (2) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation, totaling 440 mcg of epinephrine base equivalent).
(4) PK blood samples will be taken from a vein in a hand or arm via an indwelling anticoagulated IV catheter, or by venipunctures, at scheduled time points of predose baseline (within 30 minutes of dosing), and at 2±1, 5±1, 7.5±1, 10±1, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 minutes postdose. The total volume of blood taken per subject shall not exceed 500 mL in any 30-day period. Study visit schedule may be adjusted to avoid overdrawing blood in any 30-day period.
(5) At each PK sampling point, blood samples (~ 5mL), will be collected in ice-chilled potassium-EDTA sample tubes, each containing pre-added 1% (V:V) of a 1.0 M sodium metabisulfite solution as an antioxidant. Sample tubes will be labeled with a sample ID# (consisting of subject ID#, Study Visit#, and sample#). The sample tubes will be kept on ice or refrigerated, and will be centrifuged within 60 minutes of collection. The harvested plasma from each sample tube will be transferred to, and stored in, 2 storage tubes, respectively, and frozen at NMT -20 degrees C until analysis.
(6) PK samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 5 pg/mL, for both epinephrine-d3 (MW=186) and epinephrine (MW=183).
(7) 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 at the end of, or within 7 days after, Study Visit-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm T-Epinephrine Inhalation Aerosol HFA | Experimental | Drug: Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalationExperimental arm utilizing Epinephrine HFA-MDI (E004) |
| Arm C-Epinephrine Inhalation Aerosol CFC | Active comparator | Drug: Arm C-Epinephrine Inhalation Aerosol CFCActive comparator arm utilizing Epinephrine CFC-MDI |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Generally healthy, male and female adults, 18-30 yrs of age at Screening
- Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses, per investigator discretion;
- Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive
- Sitting blood pressure less than or equal to 135/90 mmHg;
- Demonstrating negative alcohol/drug screen tests;
Key exclusion criteria (7 listed)
- A smoking history of more than or equal to 10 pack-years, or having smoked within 6 months prior to Screening;
- Upper respiratory tract infections within 2 weeks, or lower respiratory tract infection within 4 weeks, prior to Screening
- Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including but not limited to: asthma, COPD, cystic fibrosis, bronchiectasis, tuberculosis, emphysema, etc.
- Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine (including diabetes), psychiatric, neoplastic or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study
- Known intolerance or hypersensitivity to any of the study MDI ingredients (i.e., epinephrine, HFA-134a, CFC-12, CFC-114, polysorbate-80, ethanol, thymol, nitric acid and ascorbic acid)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalationEpinephrine Inhalation Aerosol HFA, Single dose 125 mcg, 1 inhalation | Drug | Arm T-Epinephrine Inhalation Aerosol HFA |
| Arm C-Epinephrine Inhalation Aerosol CFCAlso: Primatene MistEpinephrine Inhalation Aerosol - CFC, Single dose 220 mcg, 1 inhalation | Drug | Arm C-Epinephrine Inhalation Aerosol CFC |
Primary outcome
Calculation and Comparison of relative Bioavailability of Epinephrine
Time frame: up to 30 min predose and at 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 minutes postdose
Blood PK samples will be collected at each visit for both study arms, then the Area Under the Curve (s) will be calculated for both arms and compared to give relative bioavailability
4 secondary outcomes
Vital Signs
Time frame: up to 30 min predose and at 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 minutes postdose
12-lead ECG (Routine and QT/QTc analysis)
Time frame: up to 30 min predose and at 5, 10, 15, 20, 30, 60, 120, and 360 minutes postdose
Physical Examinations
Time frame: up to 30 min predose and after 360 min post last dose
Lab tests
Time frame: up to 30 min predose
Results and safety
The study was stopped early (reason given: unable to validate analytical method). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Background: PubMed 2019665Pinnas JL, Schachtel BP, Chen TM, Roseberry HR, Thoden WR. Inhaled epinephrine and oral theophylline-ephedrine in the treatment of asthma. J Clin Pharmacol. 1991 Mar;31(3):243-7. doi: 10.1002/j.1552-4604.1991.tb04969.x.
- Background: PubMed 16400891Hendeles L, Marshik PL, Ahrens R, Kifle Y, Shuster J. Response to nonprescription epinephrine inhaler during nocturnal asthma. Ann Allergy Asthma Immunol. 2005 Dec;95(6):530-4. doi: 10.1016/S1081-1206(10)61014-9.
- Background: PubMed 3780129Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8. doi: 10.1038/clpt.1986.243.
- Background: PubMed 10919679Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 2000 Jun;94 Suppl B:S3-9.
- Background: PubMed 10936150Dickinson BD, Altman RD, Deitchman SD, Champion HC. Safety of over-the-counter inhalers for asthma: report of the council on scientific affairs. Chest. 2000 Aug;118(2):522-6. doi: 10.1378/chest.118.2.522.
- Background: PubMed 10535697Kushner DJ, Baker A, Dunstall TG. Pharmacological uses and perspectives of heavy water and deuterated compounds. Can J Physiol Pharmacol. 1999 Feb;77(2):79-88.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Evilevitch, M.D. study director
Amphastar Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation and Arm C-Epinephrine Inhalation Aerosol CFC in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: unable to validate analytical method). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation and Comparison of relative Bioavailability of Epinephrine (time frame: up to 30 min predose and at 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 minutes postdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01737892, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.