Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide/formoterol Easyhaler; Drug: Symbicort Turbuhaler; Drug: Charcoal and Budesonide/formoterol Easyhaler; Drug: Charcoal and Symbicort Turbuhaler

• Registration Number: NCT01627158
• 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 Start: 2012-06
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-25
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-12
• Last Update Posted: 2012-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Written informed consent (IC) obtained.
2. Males and females, 18-60 (inclusive) years of age.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Budesonide/formoterol Easyhaler	Budesonide/formoterol Easyhaler	Budesonide/formoterol Easyhaler
Symbicort Turbuhaler	Symbicort Turbuhaler	Symbicort Turbuhaler
Charcoal and Budesonide/formoterol Easyhaler	Charcoal and Budesonide/formoterol Easyhaler	-
Charcoal and Symbicort Turbuhaler	Charcoal and Symbicort Turbuhaler	-

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)

PAREXEL International GmbH; 🇩🇪 Berlin, Germany