Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler With Seretide Diskus
Information source: Orion Corporation, Orion Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Seretide Diskus and charcoal (Drug); Seretide Diskus (Drug); SF Easyhaler and charcoal (Drug); SF Easyhaler (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Orion Corporation, Orion Pharma
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary outcome: Pharmacokinetic parameter Cmax of plasma salmeterol concentrationPharmacokinetic parameter Cmax of plasma fluticasone propionate concentration Pharmacokinetic parameter AUCt of plasma salmeterol concentration Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Orion Pharma Clinical Pharmacology Unit, Espoo, Finland
Additional Information
Starting date: May 2013
Last updated: January 2, 2014
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