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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide/formoterol Easyhaler 320/9 microg; Drug: Symbicort Turbuhaler forte

• Registration Number: NCT01386996
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-30
• Study Start: 2011-07
• Study First Posted: 2011-07-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Budesonide/formoterol Easyhaler	Budesonide/formoterol Easyhaler 320/9 microg	-
Symbicort Turbuhaler	Symbicort Turbuhaler forte	-
Charcoal and Budesonide/formoterol Easyhaler	Budesonide/formoterol Easyhaler 320/9 microg	-
Charcoal and Symbicort Turbuhaler	Symbicort Turbuhaler forte	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter Cmax of plasma budesonide concentration	within 12 h
Pharmacokinetic parameter AUCt of plasma budesonide concentration	12 h
Pharmacokinetic parameter Cmax of plasma formoterol concentration	24 h
Pharmacokinetic parameter AUCt of plasma formoterol concentration	24 h

Trial Locations

Locations (1)

Orion Pharma Phase I Unit; 🇫🇮 Espoo, Finland