Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus
1 other identifier
interventional
64
1 country
1
Brief Summary
Pharmacokinetic study comparing Salmeterol/fluticasone Easyhaler products and Seretide Diskus 50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in healthy subjects
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 Jul 2016
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
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 17, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedMarch 3, 2017
August 1, 2016
4 months
February 17, 2017
March 2, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax of plasma salmeterol and fluticasone propionate
0 hour to 34 hours after study treatment administration
AUCt of plasma salmeterol and fluticasone propionate
0 hour to 34 hours after study treatment administration
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
Seretide Diskus
ACTIVE COMPARATORSingle dose of Seretide Diskus
Seretide Diskus with charcoal
ACTIVE COMPARATORSingle dose of Seretide Diskus with concomitant charcoal administration
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, hematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
- any condition requiring 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
Iissa Kivistö
Clinical Study director
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
February 17, 2017
First Posted
February 23, 2017
Study Start
July 1, 2016
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
March 3, 2017
Record last verified: 2016-08