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Pharmacokinetic Pilot Study on Budesonide/Formoterol

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ClinicalTrials.gov Identifier: NCT01457716
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief Summary:
The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.

Condition or disease Intervention/treatment Phase
Healthy Drug: Budesonide Drug: Formoterol Device: Easyhaler Device: Turbohaler Forte Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study Start Date : October 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Budesonide/Formoterol Easyhaler A Drug: Budesonide
Single inhalation
Drug: Formoterol
Single inhalation
Device: Easyhaler
Inhaler device
Experimental: Budesonide/Formoterol Easyhaler B Drug: Budesonide
Single inhalation
Drug: Formoterol
Single inhalation
Device: Easyhaler
Inhaler device
Experimental: Budesonide/Formoterol Easyhaler C Drug: Budesonide
Single inhalation
Drug: Formoterol
Single inhalation
Device: Easyhaler
Inhaler device
Active Comparator: Budesonide/Formoterol Turbohaler Forte Drug: Budesonide
Single inhalation
Drug: Formoterol
Single inhalation
Device: Turbohaler Forte
Inhaler device



Primary Outcome Measures :
  1. Cmax of Budesonide and Formoterol [ Time Frame: 24 hours ]
  2. AUCt of Budesonide and Formoterol [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. AUCinf of Budesonide and Formoterol [ Time Frame: 24 hours ]
  2. tmax of Budesonide and Formoterol [ Time Frame: 24 hours ]
  3. t1/2 of Budesonide and Formoterol [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females, 18-55 years of age.
  • Normal weight at least 50 kg.

Exclusion Criteria:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
  • Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
  • Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
  • Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
  • Pregnant or 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): NCT01457716


Locations
Germany
Parexel International GmbH
Berlin, Germany
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Study Director: Johanna Hietamäki, MSc Orion Corporation, Orion Pharma

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01457716     History of Changes
Other Study ID Numbers: 3103007
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Orion Corporation, Orion Pharma:
Healthy volunteer study

Additional relevant MeSH terms:
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
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