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Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00868426
First received: March 24, 2009
Last updated: August 12, 2009
Last verified: July 2009
History of Changes
  Purpose

The aim of this pilot study is to assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage for the future bioequivalence studies. In addition, PK of budesonide and formoterol after administration from 2 different batches of Symbicort TH is compared with each other.


Condition Intervention Phase
Healthy
 Drug: Budesonide/Formoterol Batch 1
Drug: Budesonide/Formoterol Batch 2
Drug: Budesonide/Formoterol Batch 1 and charcoal
 Phase 1

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 Inhaler, Symbicort Turbuhaler; an Open, Single Center, Single Dose Study With 3-way Crossover Design in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of budesonide and formoterol after administration of two different batches of Symbicort Turbuhaler [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Budesonide/Formoterol Batch 1
 Drug: Budesonide/Formoterol Batch 1
Single, inhaled dose
Other Name: Symbicort Turbuhaler
Experimental: 2
Budesonide/Formoterol Batch 2
 Drug: Budesonide/Formoterol Batch 2
Single, inhaled dose
Other Name: Symbicort Turbuhaler
Experimental: 3
Budesonide/Formoterol Batch 1 and charcoal
 Drug: Budesonide/Formoterol Batch 1 and charcoal
Single, inhaled dose
Other Name: Symbicort Turbuhaler

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health ascertained by detailed medical history, and laboratory and physical examinations
  • Finnish speaking males and females, 18-55 (inclusive) years of age
  • Normal weight defined as body mass index (BMI) > 19 and < 30 kg/m2
  • Weight at least 50 kg
  • Regular intestinal transit

Exclusion Criteria:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease
  • Any abnormal value of laboratory, vital signs, 12-lead electrocardiogram or physical exam which may in the opinion of the investigator interfere with the test results or cause a health risk for the subject if he/she takes part into the study
  • Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study
  • Known hypersensitivity to the active substance(s) or to any of the excipients of the drug
  • Pregnant or lactating females
  • Recent or current (suspected) drug abuse or positive result in the drugs abuse test
  • Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females [1 unit = 4 cl spirits or equivalent])
  • Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study
  • Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24 h after study treatment administration
  • Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration
  • Administration of another investigational drug within 90 days prior to the first study treatment administration
  • Unsuitable veins for repeated venipuncture or for cannulation
  • Inability to learn the correct inhalation technique
  • Inability to participate in all treatment periods
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868426

Locations
Finland
Orion Pharma Phase I Unit
Espoo, Finland, 02101
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Kimmo Ingman, MD, PhD Orion Corporation, Orion Pharma
  More Information

No publications provided

Responsible Party: Ulla Sairanen, Clinical study director, Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT00868426     History of Changes
Other Study ID Numbers: 3103001
Study First Received: March 24, 2009
Last Updated: August 12, 2009
Health Authority: Finland: Finnish Medicines Agency

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

Additional relevant MeSH terms:
Charcoal
Budesonide
Formoterol
Symbicort
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
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 May 23, 2013