Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS

Amphastar Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Arm T1: Primatene Mist HFA; Drug: Arm T2: Primatene Mist HFA; Drug: Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01255709

API-E004-CL-B3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

Arm T1 Primatene Mist HFA

Experimental group

Description:

epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes

Treatment:

Drug: Arm T1: Primatene Mist HFA

Arm C Primatene Mist

Active Comparator group

Description:

epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes

Treatment:

Drug: Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)

Arm T2 Primatene Mist HFA

Experimental group

Description:

epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes

Treatment:

Drug: Arm T2: Primatene Mist HFA