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Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte (ADECO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01627158
First received: June 21, 2012
Last updated: October 12, 2012
Last verified: October 2012
  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
Drug: Symbicort Turbuhaler
Drug: Charcoal and Budesonide/formoterol Easyhaler
Drug: Charcoal and Symbicort Turbuhaler
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Double-dummy, 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:
  • 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: 72
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Budesonide/formoterol Easyhaler
Budesonide/formoterol Easyhaler
Drug: Budesonide/formoterol Easyhaler
Budesonide/formoterol Easyhaler
Active Comparator: Symbicort Turbuhaler
Symbicort Turbuhaler
Drug: Symbicort Turbuhaler
Symbicort Turbuhaler
Experimental: Charcoal and Budesonide/formoterol Easyhaler Drug: Charcoal and Budesonide/formoterol Easyhaler
Charcoal and Budesonide/formoterol Easyhaler
Active Comparator: Charcoal and Symbicort Turbuhaler Drug: Charcoal and Symbicort Turbuhaler
Charcoal and Symbicort Turbuhaler

  Eligibility

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

Inclusion Criteria:

  1. Written informed consent (IC) obtained.
  2. Males and females, 18-60 (inclusive) years of age.

Exclusion Criteria:

  1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
  2. 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.
  3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
  4. Known hypersensitivity to the active substance(s) or the excipient of the drug.
  5. Pregnant or lactating females.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627158

Locations
Germany
PAREXEL International GmbH
Berlin, Germany, 14050
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Study Director: Irja Korpela, MSc Orion Corporation, Orion Pharma
Principal Investigator: Rainard Fuhr, Dr. med. Parexel Berlin
  More Information

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01627158     History of Changes
Other Study ID Numbers: 3103011
Study First Received: June 21, 2012
Last Updated: October 12, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on November 24, 2014