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
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: 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
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
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
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014