Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus
1 other identifier
interventional
129
1 country
1
Brief Summary
The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 asthma
Started Jun 2014
Typical duration for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 29, 2015
September 1, 2015
1.3 years
June 5, 2014
September 28, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax of plasma salmeterol and fluticasone propionate
within 34 h
AUCt of plasma salmeterol and fluticasone propionate
34 h
Study Arms (4)
Salmeterol/fluticasone Easyhaler
EXPERIMENTALSingle dose of Salmeterol/fluticasone Easyhaler
Salmeterol/fluticasone Easyhaler with charcoal
EXPERIMENTALSingle dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration (Carbomix granules)
Seretide Diskus
ACTIVE COMPARATORSingle dose of Seretide Diskus
Seretide Diskus with charcoal
ACTIVE COMPARATORSingle dose of Seretide Diskus with concomitant charcoal administration (Carbomix granules)
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent obtained
- Good general health ascertained by detailed medical history, and laboratory and physical examinations
You may not qualify if:
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed
- Known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug
- Pregnant or lactating females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orion Pharma Pharmacology Unit
Espoo, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Merja Mäkitalo
Orion Corporation, Orion Pharma
- PRINCIPAL INVESTIGATOR
Leena Mattila, MD, PhD
Orion Pharma Clinical Pharmacology Unit, Espoo, Finland
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 12, 2014
Study Start
June 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
September 29, 2015
Record last verified: 2015-09