Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte (ADECO)
This study has been completed.
Sponsor:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01627158
First received: June 21, 2012
Last updated: October 12, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Budesonide/formoterol Easyhaler Drug: Symbicort Turbuhaler Drug: Charcoal and Budesonide/formoterol Easyhaler Drug: Charcoal and Symbicort Turbuhaler |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
Drug Information available for:
Formoterol fumarate
Budesonide
Carbon, activated
Formoterol
Arformoterol Tartrate
U.S. FDA Resources
Further study details as provided by Orion Corporation, Orion Pharma:
Primary Outcome Measures:
- Pharmacokinetic parameter Cmax of plasma budesonide concentration [ Time Frame: within 12 h ] [ Designated as safety issue: No ]
- Pharmacokinetic parameter AUCt of plasma budesonide concentration [ Time Frame: 12 h ] [ Designated as safety issue: No ]
- Pharmacokinetic parameter Cmax of plasma formoterol concentration [ Time Frame: 24 h ] [ Designated as safety issue: No ]
- Pharmacokinetic parameter AUCt of plasma formoterol concentration [ Time Frame: 24 h ] [ Designated as safety issue: No ]
| Enrollment: | 72 |
| Study Start Date: | June 2012 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Budesonide/formoterol Easyhaler
Budesonide/formoterol Easyhaler
|
Drug: Budesonide/formoterol Easyhaler
Budesonide/formoterol Easyhaler
|
|
Active Comparator: Symbicort Turbuhaler
Symbicort Turbuhaler
|
Drug: Symbicort Turbuhaler
Symbicort Turbuhaler
|
| Experimental: Charcoal and Budesonide/formoterol Easyhaler |
Drug: Charcoal and Budesonide/formoterol Easyhaler
Charcoal and Budesonide/formoterol Easyhaler
|
| Active Comparator: Charcoal and Symbicort Turbuhaler |
Drug: Charcoal and Symbicort Turbuhaler
Charcoal and Symbicort Turbuhaler
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Written informed consent (IC) obtained.
- Males and females, 18-60 (inclusive) years of age.
Exclusion Criteria:
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- 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.
- 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 the excipient of the drug.
- Pregnant or lactating females.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627158
Locations
| Germany | |
| PAREXEL International GmbH | |
| Berlin, Germany, 14050 | |
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
| Study Director: | Irja Korpela, MSc | Orion Corporation, Orion Pharma |
| Principal Investigator: | Rainard Fuhr, Dr. med. | Parexel Berlin |
More Information
No publications provided
| Responsible Party: | Orion Corporation, Orion Pharma |
| ClinicalTrials.gov Identifier: | NCT01627158 History of Changes |
| Other Study ID Numbers: | 3103011 |
| Study First Received: | June 21, 2012 |
| Last Updated: | October 12, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Charcoal Budesonide Formoterol Symbicort Antidotes Protective Agents |
Physiological Effects of Drugs Pharmacologic Actions Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
ClinicalTrials.gov processed this record on May 19, 2013