ClinicalTrials.gg
Sign In
CompletedNCT01143051Updated Sep 25, 2018Results posted

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

A Phase 1/2 interventional study of epinephrine inhalation aerosol and epinephrine inhalation aerosol in Asthma, sponsored by Amphastar Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-25.

Sponsored by Amphastar Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Asthma

Browse trials for

Keywords

  • Asthma
  • Pharmacokinetics
  • Epinephrine
  • Bronchodilator
  • metered dose inhaler
03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's enrollment of 24 is below the median of 78 across 3,341 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Generally healthy, male and female adults, 18-30 yrs of age at Screening;
  • Having no respiratory, cardiovascular and other systemic or organic illnesses, per investigator discretion;
  • Women of must be non-pregnant, non-lactating, and practicing a clinically acceptable form of ;
  • Having properly consented and satisfied all other inclusion/exclusion criteria as required for this protocol.
  • Other criteria apply.

Exclusion criteria

Exclusion Criteria:

  • A recent or significant smoking history;
  • Use of prohibited drugs or failure to observe the drug restrictions;
  • Having been on other drug/device studies in the last 30 days prior to Screening.
  • Other criteria apply
Terms in these criteria, in plain language(5)

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.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

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.

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.

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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Treatment C

    Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.

    Drug: epinephrine inhalation aerosol

  • Experimental
    Treatment 1

    T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation

    Drug: epinephrine inhalation aerosol

  • Experimental
    Treatment 2

    HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation

    Drug: epinephrine inhalation aerosol

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0 to 30 minutes prior to dosing

  2. 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.

    Time frame: Pre-dose to 6 hours post-dose

  3. 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.

    Time frame: Pre-dose to 6 hours post-dose

  4. 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.

    Time frame: Pre-dose to 6 hours post-dose

  5. 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.

    Time frame: Pre-dose to 6 hours post-dose

  6. 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.

    Time frame: Pre-dose to 6 hours post-dose

Secondary outcomes

  1. 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.

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

  2. 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.

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

  3. 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.

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

  4. 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.

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

  5. 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.

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

  6. 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.

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

  7. 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.

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

  8. 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.

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

  9. 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.

    Time frame: Approximately 6 weeks

  10. 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.

    Time frame: Approximately 6 weeks

07

Results

Posted Jul 15, 2014

Participant flow

Participants were recruited from a specialty clinic in Cypress, CA between 04/29/2010 and 05/27/2010

Visit 1
Participant flow — Visit 1
MilestoneC, T1, T2C, T2, T1T1, C, T2T1, T2, CT2, C, T1T2, T1, C
Started444444
Completed444444
Not completed000000
3-14 Day Washout
Participant flow — 3-14 Day Washout
MilestoneC, T1, T2C, T2, T1T1, C, T2T1, T2, CT2, C, T1T2, T1, C
Started444444
Completed443444
Not completed001000
Withdrew: Withdrawal by subject001000
Visit 2
Participant flow — Visit 2
MilestoneC, T1, T2C, T2, T1T1, C, T2T1, T2, CT2, C, T1T2, T1, C
Started443444
Completed443444
Not completed000000
3-14 Day Washout
Participant flow — 3-14 Day Washout
MilestoneC, T1, T2C, T2, T1T1, C, T2T1, T2, CT2, C, T1T2, T1, C
Started443444
Completed443443
Not completed000001
Withdrew: Withdrawal by subject000001
Visit 3
Participant flow — Visit 3
MilestoneC, T1, T2C, T2, T1T1, C, T2T1, T2, CT2, C, T1T2, T1, C
Started443443
Completed443443
Not completed000000

Outcome measures

PrimaryBaseline 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.

Time frame:
0 to 30 minutes prior to dosing
Reported as:
Mean · pg/mL
Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine
pg/mLTreatment T1Treatment T2Treatment C
Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine9.3 ± 17.78.9 ± 15.87.8 ± 21.4
PrimaryArea 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.

Time frame:
Pre-dose to 6 hours post-dose
Reported as:
Mean · pg*min/mL
Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])
pg*min/mLTreatment T1Treatment T2Treatment C
Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])7938 ± 50239438 ± 48197218 ± 6489
PrimaryPeak 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.

Time frame:
Pre-dose to 6 hours post-dose
Reported as:
Mean · pg/mL
Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose
pg/mLTreatment T1Treatment T2Treatment C
Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose340 ± 294444 ± 328139 ± 98
PrimaryTime 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.

Time frame:
Pre-dose to 6 hours post-dose
Reported as:
Mean · min
Time to Reach Peak Concentration (Tmax) for Total Epinephrine
minTreatment T1Treatment T2Treatment C
Time to Reach Peak Concentration (Tmax) for Total Epinephrine34.6 ± 100.237.0 ± 104.538.0 ± 104.3
PrimaryHalf-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.

Time frame:
Pre-dose to 6 hours post-dose
Reported as:
Mean · min
Half-life (t1/2) for Total Epinephrine
minTreatment T1Treatment T2Treatment C
Half-life (t1/2) for Total Epinephrine125.9 ± 183.3158.8 ± 238.0237.3 ± 175.2
PrimaryConcentration 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.

Time frame:
Pre-dose to 6 hours post-dose
Reported as:
Mean · pg/mL
Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose
pg/mLTreatment T1Treatment T2Treatment C
Total Epinephrine, 0 min (Baseline)9.3 ± 17.78.9 ± 15.87.8 ± 21.4
Total Epinephrine, 5 min post-dose339.6 ± 295.1442.4 ± 330.8130.2 ± 101.8
Total Epinephrine, 15 min post-dose48.9 ± 33.762.4 ± 42.538.5 ± 21.2
Total Epinephrine, 30 min post-dose12.7 ± 18.817.4 ± 18.316.8 ± 17.6
Total Epinephrine, 45 min post-dose8.6 ± 14.413.0 ± 17.220.9 ± 18.6
Total Epinephrine, 60 min post-dose7.6 ± 14.714.5 ± 17.318.0 ± 18.6
Total Epinephrine, 90 min post-dose5.7 ± 11.613.7 ± 14.816.7 ± 16.6
Total Epinephrine, 120 min post-dose8.7 ± 12.815.5 ± 19.713.1 ± 17.6
Total Epinephrine, 180 min post-dose12.0 ± 20.210.4 ± 15.28.4 ± 15.2
Total Epinephrine, 240 min post-dose12.9 ± 20.411.5 ± 14.99.8 ± 18.1
Total Epinephrine, 360 min post-dose31.1 ± 24.029.4 ± 23.038.3 ± 40.8
SecondaryVital 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.

Time frame:
Pre-dose (baseline) to 360 minutes post-dose
Reported as:
Mean · mmHg
Vital Signs: Systolic Blood Pressure (SBP)
mmHgTreatment T1Treatment T2Treatment C
Pre-dose (Baseline)110 ± 10.0112 ± 13.2111 ± 9.4
10 min post-dose123 ± 13.8122 ± 14.1121 ± 11.3
30 min post-dose116 ± 12.3117 ± 11.5116 ± 10.6
60 min post-dose113 ± 11.2113 ± 9.9115 ± 10.0
120 min post-dose112 ± 10.4114 ± 9.6114 ± 10.9
180 min post-dose114 ± 10.1113 ± 11.4115 ± 11.0
360 min post-dose113 ± 9.8113 ± 9.3113 ± 9.5
SecondaryVital 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.

Time frame:
Pre-dose (baseline) to 360 minutes post-dose
Reported as:
Mean · mmHg
Vital Signs: Diastolic Blood Pressure (DBP)
mmHgTreatment T1Treatment T2Treatment C
Pre-dose (Baseline)62 ± 9.361 ± 11.261 ± 10.8
10 min post-dose63 ± 10.164 ± 10.065 ± 10.2
30 min post-dose64 ± 11.264 ± 9.265 ± 9.5
60 min post-dose63 ± 10.864 ± 10.463 ± 8.8
120 min post-dose61 ± 9.863 ± 11.962 ± 10.6
180 min post-dose62 ± 8.360 ± 9.559 ± 7.5
360 min post-dose62 ± 8.862 ± 10.162 ± 8.0
SecondaryVital 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.

Time frame:
Pre-dose (baseline) to 360 minutes post-dose
Reported as:
Mean · beats per minute
Vital Signs: Heart Rate (HR)
beats per minuteTreatment T1Treatment T2Treatment C
Pre-dose (Baseline)60 ± 10.162 ± 12.258 ± 11.7
10 min post-dose67 ± 14.069 ± 12.262 ± 12.7
30 min post-dose63 ± 14.264 ± 9.861 ± 13.7
60 min post-dose67 ± 12.967 ± 14.461 ± 10.8
120 min post-dose60 ± 10.160 ± 7.158 ± 9.4
180 min post-dose66 ± 11.166 ± 10.563 ± 9.9
360 min post-dose64 ± 8.764 ± 10.461 ± 8.4
SecondaryECG: 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.

Time frame:
Pre-dose (baseline) to 360 minutes post-dose
Reported as:
Mean · msec
ECG: QT Interval
msecTreatment T1Treatment T2Treatment C
Pre-dose (Baseline)416 ± 33.6407 ± 30.1423 ± 44.1
30 min post-dose404 ± 38.6405 ± 32.8413 ± 44.8
90 min post-dose399 ± 34.3401 ± 32.9407 ± 41.3
360 min post-dose399 ± 41.5400 ± 33.1400 ± 37.7
SecondaryECG: 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.

Time frame:
Pre-dose (baseline) to 360 minutes post-dose
Reported as:
Mean · msec
ECG: QTc Interval
msecTreatment T1Treatment T2Treatment C
Pre-dose (Baseline)407 ± 16.9407 ± 20.0403 ± 16.2
30 min post-dose408 ± 15.2411 ± 19.4412 ± 22.3
90 min post-dose401 ± 16.9401 ± 18.1403 ± 14.1
360 min post-dose403 ± 18.2403 ± 17.9402 ± 15.7
SecondarySerum 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.

Time frame:
Pre-dose (baseline) to 360 minutes post-dose
Reported as:
Mean · mg/dL
Serum Glucose Levels
mg/dLTreatment T1Treatment T2Treatment C
Pre-dose (Baseline)83 ± 6.983 ± 9.184 ± 6.2
15 min post-dose101 ± 17.0105 ± 11.696 ± 11.0
30 min post-dose94 ± 16.499 ± 12.198 ± 10.7
60 min post-dose86 ± 8.986 ± 10.894 ± 12.5
120 min post-dose81 ± 6.882 ± 6.183 ± 5.3
360 min post-dose82 ± 7.982 ± 9.480 ± 7.1
SecondarySerum 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.

Time frame:
Pre-dose (baseline) to 360 minutes post-dose
Reported as:
Mean · mmol/L
Serum Potassium Levels
mmol/LTreatment T1Treatment T2Treatment C
Pre-dose (Baseline)4 ± 0.24 ± 0.34 ± 0.2
15 min post-dose4 ± 0.34 ± 0.34 ± 0.3
30 min post-dose4 ± 0.54 ± 0.34 ± 0.3
60 min post-dose4 ± 0.24 ± 0.34 ± 0.2
120 min post-dose4 ± 0.34 ± 0.34 ± 0.3
360 min post-dose4 ± 0.34 ± 0.34 ± 0.2
SecondaryHand 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.

Time frame:
Pre-dose (baseline) to 360 minutes post-dose
Reported as:
Mean · score on a scale
Hand Tremor Scores
score on a scaleTreatment T1Treatment T2Treatment C
Pre-dose (Baseline)0.0 ± 0.00.0 ± 0.00.0 ± 0.0
10 min post-dose0.1 ± 0.30.2 ± 0.40.1 ± 0.4
60 min post-dose0.0 ± 0.00.0 ± 0.00.0 ± 0.2
360 min post-dose0.0 ± 0.00.0 ± 0.00.0 ± 0.2
SecondaryNumber 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.

Time frame:
Approximately 6 weeks
Reported as:
Count of participants · Participants
Number of Subjects With Significant Changes in Physical Examination
ParticipantsRandomized Subjects
Number of Subjects With Significant Changes in Physical Examination0
SecondaryNumber 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.

Time frame:
Approximately 6 weeks
Reported as:
Count of participants · Participants
Number of Subjects With Significant Changes in Laboratory Tests
ParticipantsRandomized Subjects
Number of Subjects With Significant Changes in Laboratory Tests0

Adverse events

Collected over All patients were closely monitored for any incidence of adverse events by the investigators during the entire study period.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment T1—0/24 (0%)1/24 (4.2%)
Treatment T2—0/23 (0%)1/23 (4.3%)
Treatment C—0/22 (0%)1/22 (4.5%)
Most frequent other events
Most frequent other events
EventTreatment T1Treatment T2Treatment C
NauseaGastrointestinal disorders1/240/231/22
Sore throatGastrointestinal disorders0/240/231/22
LightheadednessNervous system disorders0/240/231/22
Upset stomachGastrointestinal disorders0/241/230/22
VomitingGastrointestinal disorders1/240/230/22

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)C, T1, T2C, T2, T1T1, C, T2T1, T2, CT2, C, T1T2, T1, CTotal
<=18 years0000000
Between 18 and 65 years44444424
>=65 years0000000
Age, Continuous
Age, Continuous(years)C, T1, T2C, T2, T1T1, C, T2T1, T2, CT2, C, T1T2, T1, CTotal
Mean24.0 ± 2.9425.3 ± 4.2724.0 ± 3.3721.8 ± 1.7125.3 ± 0.5022.0 ± 3.5623.7 ± 3.01
Sex: Female, Male
Sex: Female, Male(Participants)C, T1, T2C, T2, T1T1, C, T2T1, T2, CT2, C, T1T2, T1, CTotal
Female1212129
Male32323215
Region of Enrollment
Region of Enrollment(participants)C, T1, T2C, T2, T1T1, C, T2T1, T2, CT2, C, T1T2, T1, CTotal
United States44444424
08

Study locations

1 site
  • Amphastar Location 1
    Cypress, California 90630, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01143051
Lead sponsor
Amphastar Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jun 14, 2010
Start date
Jan 2010
Primary completion
Jun 2010
Completion
Jun 2010
Results posted
Jul 15, 2014
Last update
Sep 25, 2018

Study contacts

Medical Director
study director · Amphastar Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Epinephrine

Other studies in this condition

Asthma →

Other studies from this sponsor

Amphastar Pharmaceuticals, Inc.

Start the discussion