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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
Sponsor:
Information provided by (Responsible Party):
Amphastar Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 3, 2010
First Posted Date  ICMJE December 7, 2010
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE December 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS
Official Title  ICMJE CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers
Brief Summary This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (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.
Detailed Description The current study is designed to complement and expand the previous PK studies, API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004 will also be evaluated, under augmented dose conditions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Arm T1: Primatene Mist HFA
    epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes
    Other Name: epinephrine inhalation aerosol
  • Drug: Arm T2: Primatene Mist HFA
    epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes
    Other Name: epinephrine inhalation aerosol
  • 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
Study Arms  ICMJE
  • Experimental: Arm T1 Primatene Mist HFA
    epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes
    Intervention: Drug: Arm T1: Primatene Mist HFA
  • Active Comparator: Arm C Primatene Mist
    epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes
    Intervention: Drug: Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)
  • Experimental: Arm T2 Primatene Mist HFA
    epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes
    Intervention: Drug: Arm T2: Primatene Mist HFA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2011)
24
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2010)
18
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01255709
Other Study ID Numbers  ICMJE API-E004-CL-B3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amphastar Pharmaceuticals, Inc.
Study Sponsor  ICMJE Amphastar Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Amphastar Pharmaceuticals, Inc.
PRS Account Amphastar Pharmaceuticals, Inc.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP