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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03060044 |
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Date of registration:
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17/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus
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Scientific title:
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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 |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03060044 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Finland
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Contacts
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Name:
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Iissa Kivistö |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinical Study director |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- written informed consent obtained
- good general health ascertained by detailed medical history, and laboratory and
physical examinations
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: Seretide Diskus
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Drug: Seretide Diskus with charcoal
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Drug: Salmeterol/fluticasone Easyhaler
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Drug: Salmeterol/fluticasone Easyhaler with charcoal
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Primary Outcome(s)
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Cmax of plasma salmeterol and fluticasone propionate
[Time Frame: 0 hour to 34 hours after study treatment administration]
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AUCt of plasma salmeterol and fluticasone propionate
[Time Frame: 0 hour to 34 hours after study treatment administration]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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