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Trial record 29 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

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ClinicalTrials.gov Identifier: NCT03073057
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide/formoterol Other: Charcoal Drug: Symbicort Turbuhaler Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Pilot Study Comparing Three Formulations of Budesonide/Formoterol Easyhaler 160/4.5 Microg/Inhalation and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Actual Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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Arm Intervention/treatment
Experimental: Charcoal and Budesonide/formoterol Easyhaler A
160/4.5microg/inhalation Charcoal
Drug: Budesonide/formoterol
2 inhalations as a single dose
Other Name: Budesonide/formoterol 160/4.5microg

Other: Charcoal
Experimental: Charcoal and Budesonide/formoterol Easyhaler B
160/4.5microg/inhalation Charcoal
Drug: Budesonide/formoterol
2 inhalations as a single dose
Other Name: Budesonide/formoterol 160/4.5microg

Other: Charcoal
Experimental: Charcoal and Budesonide/formoterol Easyhaler C
160/4.5microg/inhalation Charcoal
Drug: Budesonide/formoterol
2 inhalations as a single dose
Other Name: Budesonide/formoterol 160/4.5microg

Other: Charcoal
Active Comparator: Charcoal and Symbicort Turbuhaler
160/4.5microg/inhalation Charcoal
Other: Charcoal
Drug: Symbicort Turbuhaler
2 inhalations as a single dose
Other Name: Symbicort Turbuhaler 160/4.5 microg




Primary Outcome Measures :
  1. Cmax of plasma budesonide and formoterol [ Time Frame: within 24 hours ]
  2. AUCt of plasma budesonide and formoterol [ Time Frame: within 24 hours ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent obtained
  • Body mass index > 19 and < 30kg/m2, weight at least 50 kg
  • Good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion Criteria:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease
  • Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during a study.
  • Known hypersensitivity to the active substance(s) or the excipient of the drug
  • Pregnant and lactating females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073057


Locations
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Finland
Orion Pharma, Clinical Pharmacology Unit
Espoo, Finland, 02100
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Study Director: Iissa Kivisto Orion Corporation, Orion Pharma
Principal Investigator: Leena Mattila, MD Orion Pharma, Clinical Pharmacology Unit, Espoo, Finland

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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03073057     History of Changes
Other Study ID Numbers: 3103014
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: February 2016

Additional relevant MeSH terms:
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Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Charcoal
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antidotes
Protective Agents