Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler With Seretide Diskus
Pharmacokinetic Study Comparing Two Salmeterol Fluticasone Propionate Device-metered Dry Powder Inhalers, Salmeterol/Fluticasone Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; a Randomised, Doubleblind,Single Centre, Single Dose, Crossover Study in Healthy Subjects
1 other identifier
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 asthma
Started May 2013
Shorter than P25 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 15, 2013
CompletedFirst Posted
Study publicly available on registry
May 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJanuary 3, 2014
January 1, 2014
4 months
May 15, 2013
January 2, 2014
Conditions
Outcome Measures
Primary Outcomes (4)
Pharmacokinetic parameter Cmax of plasma salmeterol concentration
Within 34 h
Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration
Within 34 h
Pharmacokinetic parameter AUCt of plasma salmeterol concentration
Within 34 h
Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration
Within 34 h
Study Arms (4)
Seretide Diskus and charcoal
ACTIVE COMPARATORSingle-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal
Seretide Diskus
ACTIVE COMPARATORSingle-dose of Seretide Diskus (50/500 mcg/inhalation)
SF Easyhaler and charcoal
EXPERIMENTALSalmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal
SF Easyhaler
EXPERIMENTALSalmeterol/fluticasone Easyhaler (50/500 mcg/inhalation)
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males and females aged 18-60 years
- Normal weight, at least 50 kg
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orion Pharma Clinical Pharmacology Unit
Espoo, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2013
First Posted
May 17, 2013
Study Start
May 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
January 3, 2014
Record last verified: 2014-01