Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler - Full Text View

Purpose

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.

Condition	Intervention	Phase
Asthma	Drug: Budesonide/formoterol Easyhaler 320/9 microg Drug: Symbicort Turbuhaler forte	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:

Pharmacokinetic parameter Cmax of plasma budesonide concentration [ Time Frame: within 12 h ] [ Designated as safety issue: No ]
Pharmacokinetic parameter AUCt of plasma budesonide concentration [ Time Frame: 12 h ] [ Designated as safety issue: No ]
Pharmacokinetic parameter Cmax of plasma formoterol concentration [ Time Frame: 24 h ] [ Designated as safety issue: No ]
Pharmacokinetic parameter AUCt of plasma formoterol concentration [ Time Frame: 24 h ] [ Designated as safety issue: No ]

Enrollment:	74
Study Start Date:	July 2011
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Charcoal and Budesonide/formoterol Easyhaler	Drug: Budesonide/formoterol Easyhaler 320/9 microg 2 inhalations as a single dose
Active Comparator: Charcoal and Symbicort Turbuhaler	Drug: Symbicort Turbuhaler forte 2 inhalations as a single dose
Experimental: Budesonide/formoterol Easyhaler	Drug: Budesonide/formoterol Easyhaler 320/9 microg 2 inhalations as a single dose
Active Comparator: Symbicort Turbuhaler	Drug: Symbicort Turbuhaler forte 2 inhalations as a single dose

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy males and females aged 18-60 years.
Normal weight, at least 50 kg.

Exclusion criteria

Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
Known hypersensitivity to the active substance(s) or the excipient of the drug.
Pregnant or lactating females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386996

Locations

Finland
Orion Pharma Phase I Unit
Espoo, Finland

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Study Director:	Ulla Sairanen, MSc	Orion Corporation, Orion Pharma
Principal Investigator:	Kimmo Ingman, MD, PhD	Orion Corporation, Orion Pharma

More Information

No publications provided

Responsible Party:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT01386996 History of Changes
Other Study ID Numbers:	3103004
Study First Received:	June 23, 2011
Last Updated:	December 21, 2011
Health Authority:	Finland: Finnish Medicines Agency Fimea

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013