AsthmaPhase 1/2NCT01143051

Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers

A Phase 1/2 study testing epinephrine inhalation aerosol in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. 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?: epinephrine inhalation aerosol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Jun 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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;
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.
Other criteria apply.

Who cannot join

A recent or significant smoking history;
Use of prohibited drugs or failure to observe the drug washout restrictions;
Having been on other investigational drug/device studies in the last 30 days prior to Screening.
Other criteria apply

Trial locations and contacts

1 site in 1 country.

United States1 site

Amphastar Location 1
Cypress, California, 90630

Other trials in United States

About this study

Official title: Phase I/II Study Epinephrine Inhalation Aerosol USP, an HFA-MDI Clinical Study-B for Assessment of Pharmacokinetics

Read the detailed description

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:
Treatment T1: Ten (10) inhalations of the low dose E004(125 mcg/inhalation), totaling 1.25 mg of epinephrine;
Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine;
Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation, totaling 2.2 mg of epinephrine base equivalent).
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.

Conditions: Asthma
Being tested: epinephrine inhalation aerosol
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.

epinephrine inhalation aerosolDrug
Also called Primatene Mist
Single dose 220 mcg/inhalation, 10 inhalations
epinephrine inhalation aerosolDrug
Also called Primatene Mist
HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations
epinephrine inhalation aerosolDrug
Also called Primatene Mist
HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations

Study groups in NCT01143051
Study group	Role	What they receive
Treatment C	Active comparator	Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose. Receives: Drug: epinephrine inhalation aerosol
Treatment 1	Experimental	T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation Receives: Drug: epinephrine inhalation aerosol
Treatment 2	Experimental	HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation Receives: Drug: epinephrine inhalation aerosol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose to 6 hours post-dose

Secondary outcomes (10)

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.
Measured: Pre-dose (baseline) to 360 minutes post-dose
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Jun 2010

First posted14 Jun 2010 (estimated)
Study startJan 2010
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01143051
Sponsor's protocol ID: API-E004-CL-B
Status last verified: Sep 2018
First submitted: 7 Jun 2010
Last updated: 25 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Study Epinephrine Inhalation Aerosol USP, an HFA-MDI Clinical Study-B for Assessment of Pharmacokinetics
ClinicalTrials.gov ID: NCT01143051
Acronym / sponsor ID: API-E004-CL-B
Conditions: Asthma
Keywords: Asthma, Pharmacokinetics, Epinephrine, Bronchodilator, metered dose inhaler
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 14 Jun 2010 (estimated)
Results: Posted 15 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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:
Treatment T1: Ten (10) inhalations of the low dose E004(125 mcg/inhalation), totaling 1.25 mg of epinephrine;
Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine;
Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation, totaling 2.2 mg of epinephrine base equivalent).
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Treatment C	Active comparator	Drug: epinephrine inhalation aerosolActive comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.
Treatment 1	Experimental	Drug: epinephrine inhalation aerosolT1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation
Treatment 2	Experimental	Drug: epinephrine inhalation aerosolHFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 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;
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.
Other criteria apply.

Key exclusion criteria (4 listed)

A recent or significant smoking history;
Use of prohibited drugs or failure to observe the drug washout restrictions;
Having been on other investigational drug/device studies in the last 30 days prior to Screening.
Other criteria apply

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
epinephrine inhalation aerosolAlso: Primatene MistSingle dose 220 mcg/inhalation, 10 inhalations	Drug	Treatment C
epinephrine inhalation aerosolAlso: Primatene MistHFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations	Drug	Treatment 1
epinephrine inhalation aerosolAlso: Primatene MistHFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations	Drug	Treatment 2

Primary outcome

Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine
Time frame: 0 to 30 minutes prior to dosing
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.
Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])
Time frame: Pre-dose 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. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.
Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose
Time frame: Pre-dose 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.
Time to Reach Peak Concentration (Tmax) for Total Epinephrine
Time frame: Pre-dose 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. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.
Half-life (t1/2) for Total Epinephrine
Time frame: Pre-dose 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. 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.
Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose
Time frame: Pre-dose 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.

10 secondary outcomes

Vital Signs: Systolic Blood Pressure (SBP)
Time frame: Pre-dose (baseline) to 360 minutes post-dose
Vital Signs: Diastolic Blood Pressure (DBP)
Time frame: Pre-dose (baseline) to 360 minutes post-dose
Vital Signs: Heart Rate (HR)
Time frame: Pre-dose (baseline) to 360 minutes post-dose
ECG: QT Interval
Time frame: Pre-dose (baseline) to 360 minutes post-dose
ECG: QTc Interval
Time frame: Pre-dose (baseline) to 360 minutes post-dose
Serum Glucose Levels
Time frame: Pre-dose (baseline) to 360 minutes post-dose
Serum Potassium Levels
Time frame: Pre-dose (baseline) to 360 minutes post-dose
Hand Tremor Scores
Time frame: Pre-dose (baseline) to 360 minutes post-dose
Number of Subjects With Significant Changes in Physical Examination
Time frame: Approximately 6 weeks
Number of Subjects With Significant Changes in Laboratory Tests
Time frame: Approximately 6 weeks

Results and safety

Results posted to the registry on 15 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
C, T1, T2	4	4
C, T2, T1	4	4
T1, C, T2	4	4
T1, T2, C	4	4
T2, C, T1	4	4
T2, T1, C	4	4

Primary outcome: Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine

Time frame: 0 to 30 minutes prior to dosing. Mean (Standard Deviation). Unit: pg/mL

Measure	Treatment T1 n = 24	Treatment T2 n = 22	Treatment C n = 22
Value	9.3 (17.7)	8.9 (15.8)	7.8 (21.4)

Population analysed: 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.

Primary outcome: Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])

Time frame: Pre-dose to 6 hours post-dose. Mean (Standard Deviation). Unit: pg*min/mL

Measure	Treatment T1 n = 24	Treatment T2 n = 22	Treatment C n = 22
Value	7938 (5023)	9438 (4819)	7218 (6489)

Primary outcome: Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose

Time frame: Pre-dose to 6 hours post-dose. Mean (Standard Deviation). Unit: pg/mL

Measure	Treatment T1 n = 24	Treatment T2 n = 22	Treatment C n = 22
Value	340 (294)	444 (328)	139 (98)

Primary outcome: Time to Reach Peak Concentration (Tmax) for Total Epinephrine

Time frame: Pre-dose to 6 hours post-dose. Mean (Standard Deviation). Unit: min

Measure	Treatment T1 n = 24	Treatment T2 n = 22	Treatment C n = 22
Value	34.6 (100.2)	37.0 (104.5)	38.0 (104.3)

Population analysed: 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.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: All patients were closely monitored for any incidence of adverse events by the investigators during the entire study period.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment T1	0 of 24 (0%)	1 of 24 (4.2%)	Not reported
Treatment T2	0 of 23 (0%)	1 of 23 (4.3%)	Not reported
Treatment C	0 of 22 (0%)	1 of 22 (4.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Medical Director 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 epinephrine inhalation aerosol 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 25 Sep 2018. 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?

Yes. Results are posted in the registry (first posted 15 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine (time frame: 0 to 30 minutes prior to dosing). The study lists 6 primary outcomes in all. 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 NCT01143051.

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 25 Sep 2018.