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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Budesonide/Formoterol Batch 1; Drug: Budesonide/Formoterol Batch 2; Drug: Budesonide/Formoterol Batch 1 and charcoal

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland, 02101
    • Orion Pharma Phase I Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Budesonide/Formoterol Batch 1	Drug: Budesonide/Formoterol Batch 1; Single, inhaled dose; Other Names: Symbicort Turbuhaler
Experimental: 2; Budesonide/Formoterol Batch 2	Drug: Budesonide/Formoterol Batch 2; Single, inhaled dose; Other Names: Symbicort Turbuhaler
Experimental: 3; Budesonide/Formoterol Batch 1 and charcoal	Drug: Budesonide/Formoterol Batch 1 and charcoal; Single, inhaled dose; Other Names: Symbicort Turbuhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of budesonide and formoterol after administration of two different batches of Symbicort Turbuhaler	1 day

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Investigators: Principal Investigator: Kimmo Ingman, MD, PhD, Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: March 24, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (Estimate): March 25, 2009

Study Record Updates

• Last Update Posted (Estimate): August 13, 2009
• Last Update Submitted That Met QC Criteria: August 12, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Healthy volunteer study
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antidotes; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Charcoal; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: 3103001