- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01766843
Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus
January 2, 2014 updated by: Orion Corporation, Orion Pharma
Bioequivalence Study Comparing Two Salmeterol/Fluticasone Propionate Dry Powder Inhalers, SF Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects
The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Espoo, Finland
- Orion Pharma Clinical Pharmacology Unit
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy males and females aged 18-60 years
- Normal weight, at least 50 kg
Exclusion Criteria:
- Evidence of 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Seretide Diskus and charcoal
Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal
|
2 inhalations as a single dose
|
Active Comparator: Seretide Diskus
Single-dose of Seretide Diskus (50/500 mcg/inhalation)
|
2 inhalations as a single dose
|
Experimental: SF Easyhaler and charcoal
Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal
|
2 inhalations as a single dose
|
Experimental: SF Easyhaler
Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation)
|
2 inhalations as a single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic parameter Cmax of plasma salmeterol concentration
Time Frame: Within 34 h
|
Within 34 h
|
Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration
Time Frame: Within 34 h
|
Within 34 h
|
Pharmacokinetic parameter AUCt of plasma salmeterol concentration
Time Frame: within 34 h
|
within 34 h
|
Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration
Time Frame: within 34 h
|
within 34 h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leena Mattila, MD, PhD, Orion Corporation, Orion Pharma
- Study Director: Maria Sokka, IRW Consulting
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
January 9, 2013
First Submitted That Met QC Criteria
January 9, 2013
First Posted (Estimate)
January 11, 2013
Study Record Updates
Last Update Posted (Estimate)
January 3, 2014
Last Update Submitted That Met QC Criteria
January 2, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antidotes
- Sympathomimetics
- Fluticasone-Salmeterol Drug Combination
- Charcoal
Other Study ID Numbers
- 3106007, EudraCT 2012-00378-41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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