Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-Metered Dry Powder Inhaler - Full Text View

Sponsored by:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00868426

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 I

Drug Information available for: Charcoal Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
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

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 ]

Estimated Enrollment:	12
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Budesonide/Formoterol Batch 1	Drug: Budesonide/Formoterol Batch 1 Single, inhaled dose
2: Experimental Budesonide/Formoterol Batch 2	Drug: Budesonide/Formoterol Batch 2 Single, inhaled dose
3: Experimental Budesonide/Formoterol Batch 1 and charcoal	Drug: Budesonide/Formoterol Batch 1 and charcoal Single, inhaled dose

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

Contacts

Contact: Kimmo Ingman, MD, PhD

+358104261

kimmo.ingman@orionpharma.com

Locations

Finland
Orion Pharma Phase I Unit	Recruiting
Espoo, Finland, 02101
Contact: Kimmo Ingman, MD, PhD +358104261 kimmo.ingman@orionpharma.com
Principal Investigator: Kimmo Ingman, MD, PhD

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:	Orion Corporation, Orion Pharma ( Johanna Hietamäki, Clinical study director )
Study ID Numbers:	3103001
Study First Received:	March 24, 2009
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00868426 History of Changes
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Orion Corporation, Orion Pharma:

Healthy volunteer study

Study placed in the following topic categories:

Charcoal
Anti-Inflammatory Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Symbicort
Hormone Antagonists
Budesonide
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Healthy
Glucocorticoids
Hormones
Adrenergic Agonists
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Symbicort
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide

Anti-Asthmatic Agents
Glucocorticoids
Hormones
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 07, 2009