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 Signs12-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
|