Comparison of Absorption of Budesonide and Formoterol 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: Charcoal and Budesonide/formoterol Easyhaler 320/9 microg Drug: Charcoal and Symbicort Turbuhaler 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 Carbon, activated 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 Cmax of plasma formoterol concentration [ Time Frame: within 24 h ] [ Designated as safety issue: No ]
Pharmacokinetic parameter AUCt of plasma budesonide concentration [ Time Frame: Within 12 h ] [ Designated as safety issue: No ]
Pharmacokinetic parameter AUCt of plasma formoterol concentration [ Time Frame: Within 24 h ] [ Designated as safety issue: No ]

Enrollment:	72
Study Start Date:	May 2012
Study Completion Date:	October 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Charcoal and Symbicort Turbuhaler	Drug: Charcoal and Symbicort Turbuhaler 2 inhalations as a single dose
Active Comparator: Symbicort Turbuhaler	Drug: Symbicort Turbuhaler forte 2 inhalations as a single dose
Experimental: Charcoal and Budesonide/formoterol Easyhaler	Drug: Charcoal and Budesonide/formoterol Easyhaler 320/9 microg 2 inhalations as a single dose
Experimental: Budesonide/formoterol Easyhaler	Drug: Budesonide/formoterol Easyhaler 320/9 microg 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: NCT01593826

Locations

Finland
Orion Pharma Clinical Pharmacology Unit
Espoo, Finland

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Principal Investigator:	Leena Mattila, MD, PhD	Orion Corporation, Orion Pharma
Study Director:	Ulla Sairanen, MSc	Orion Corporation, Orion Pharma

More Information

No publications provided

Responsible Party:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT01593826 History of Changes
Other Study ID Numbers:	3103010
Study First Received:	May 4, 2012
Last Updated:	November 21, 2012
Health Authority:	Finland: Finnish Medicines Agency

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Charcoal
Budesonide
Formoterol
Symbicort
Antidotes
Protective Agents

Physiological Effects of Drugs
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
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

ClinicalTrials.gov processed this record on May 19, 2013