Pharmacokinetic Pilot Study on Budesonide/Formoterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01457716
First received: September 28, 2011
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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 Intervention
Healthy
Drug: Budesonide
Drug: Formoterol
Device: Easyhaler
Device: Turbohaler Forte

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cmax of Budesonide and Formoterol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • AUCt of Budesonide and Formoterol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUCinf of Budesonide and Formoterol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • tmax of Budesonide and Formoterol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • t1/2 of Budesonide and Formoterol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01457716     History of Changes
Other Study ID Numbers: 3103007
Study First Received: September 28, 2011
Last Updated: February 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
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 April 17, 2014