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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593826
• Other study ID #: 3103010
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2012
• Last updated: November 21, 2012
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Charcoal and Budesonide/formoterol Easyhaler 320/9 microg
2 inhalations as a single dose
• Charcoal and Symbicort Turbuhaler
2 inhalations as a single dose
• Budesonide/formoterol Easyhaler 320/9 microg
2 inhalations as a single dose
• Symbicort Turbuhaler forte
2 inhalations as a single dose

Locations

Country	Name	City	State
Finland	Orion Pharma Clinical Pharmacology Unit	Espoo

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameter Cmax of plasma budesonide concentration		within 12 h	No
Primary	Pharmacokinetic parameter Cmax of plasma formoterol concentration		within 24 h	No
Primary	Pharmacokinetic parameter AUCt of plasma budesonide concentration		Within 12 h	No
Primary	Pharmacokinetic parameter AUCt of plasma formoterol concentration		Within 24 h	No