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

NCT ID: NCT01143051

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment C

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

Group Type: ACTIVE_COMPARATOR

epinephrine inhalation aerosol

Intervention Type: DRUG

Single dose 220 mcg/inhalation, 10 inhalations

Treatment 1

T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation

Group Type: EXPERIMENTAL

epinephrine inhalation aerosol

Intervention Type: DRUG

HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations

Treatment 2

HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation

Group Type: EXPERIMENTAL

epinephrine inhalation aerosol

Intervention Type: DRUG

HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations

Interventions

epinephrine inhalation aerosol

Single dose 220 mcg/inhalation, 10 inhalations

Intervention Type: DRUG

epinephrine inhalation aerosol

HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations

Intervention Type: DRUG

epinephrine inhalation aerosol

HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations

Intervention Type: DRUG

Other Intervention Names

Primatene Mist; Primatene Mist; Primatene Mist

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• Other criteria apply.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amphastar Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Amphastar Pharmaceuticals, Inc.

Locations

Amphastar Location 1

Cypress, California, United States

Countries

United States

Other Identifiers

API-E004-CL-B

Identifier Type: -

Identifier Source: org_study_id