Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Charcoal and Symbicort Turbuhaler; Drug: Symbicort Turbuhaler forte; Drug: Charcoal and Budesonide/formoterol Easyhaler 320/9 microg; Drug: Budesonide/formoterol Easyhaler 320/9 microg

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland
    • Orion Pharma Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy males and females aged 18-60 years.
2. Normal weight, at least 50 kg.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Charcoal and Symbicort Turbuhaler	Drug: Charcoal and Symbicort Turbuhaler; 2 inhalations as a single dose
Active Comparator: Symbicort Turbuhaler	Drug: Symbicort Turbuhaler forte; 2 inhalations as a single dose
Experimental: Charcoal and Budesonide/formoterol Easyhaler	Drug: Charcoal and Budesonide/formoterol Easyhaler 320/9 microg; 2 inhalations as a single dose
Experimental: Budesonide/formoterol Easyhaler	Drug: Budesonide/formoterol Easyhaler 320/9 microg; 2 inhalations as a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameter Cmax of plasma budesonide concentration	within 12 h
Pharmacokinetic parameter Cmax of plasma formoterol concentration	within 24 h
Pharmacokinetic parameter AUCt of plasma budesonide concentration	Within 12 h
Pharmacokinetic parameter AUCt of plasma formoterol concentration	Within 24 h

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Investigators: Principal Investigator: Leena Mattila, MD, PhD, Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: May 4, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Estimate): November 22, 2012
• Last Update Submitted That Met QC Criteria: November 21, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this 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: 3103010