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

Information source: Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Treatment arm T1 (Drug); Treatment arm T2 (Drug); Treatment arm C (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amphastar Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Amphastar Pharmaceuticals, Inc.

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.

Clinical Details

Official title: CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pharmacokinetics including maximum concentration and area under the curve

Secondary outcome:

Vital Signs

12-lead Electrocardiogram (ECG)

Telemetry ECG

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.

Eligibility

Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Amphastar Study Site 1, Cypress, California 90630, United States
Additional Information

Related publications:

Pinnas JL, Schachtel BP, Chen TM, Roseberry HR, Thoden WR. Inhaled epinephrine and oral theophylline-ephedrine in the treatment of asthma. J Clin Pharmacol. 1991 Mar;31(3):243-7.

Hendeles L, Marshik PL, Ahrens R, Kifle Y, Shuster J. Response to nonprescription epinephrine inhaler during nocturnal asthma. Ann Allergy Asthma Immunol. 2005 Dec;95(6):530-4.

Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8.

Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 2000 Jun;94 Suppl B:S3-9.

Dickinson BD, Altman RD, Deitchman SD, Champion HC. Safety of over-the-counter inhalers for asthma: report of the council on scientific affairs. Chest. 2000 Aug;118(2):522-6.

Simons FE, Gu X, Johnston LM, Simons KJ. Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? Pediatrics. 2000 Nov;106(5):1040-4.

Kushner DJ, Baker A, Dunstall TG. Pharmacological uses and perspectives of heavy water and deuterated compounds. Can J Physiol Pharmacol. 1999 Feb;77(2):79-88. Review.

Bondesson E, Friberg K, Soliman S, Löfdahl CG. Safety and efficacy of a high cumulative dose of salbutamol inhaled via Turbuhaler or via a pressurized metered-dose inhaler in patients with asthma. Respir Med. 1998 Feb;92(2):325-30.

Starting date: December 2010
Last updated: January 27, 2011

Page last updated: August 20, 2015

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