Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01766843
First received: January 9, 2013
Last updated: January 2, 2014
Last verified: January 2014

January 9, 2013
January 2, 2014
January 2013
May 2013   (final data collection date for primary outcome measure)
  • Pharmacokinetic parameter Cmax of plasma salmeterol concentration [ Time Frame: Within 34 h ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration [ Time Frame: Within 34 h ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter AUCt of plasma salmeterol concentration [ Time Frame: within 34 h ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration [ Time Frame: within 34 h ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01766843 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus
Bioequivalence Study Comparing Two Salmeterol/Fluticasone Propionate Dry Powder Inhalers, SF Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Asthma
  • Drug: Seretide Diskus and charcoal
    2 inhalations as a single dose
  • Drug: Seretide Diskus
    2 inhalations as a single dose
  • Drug: SF Easyhaler and charcoal
    2 inhalations as a single dose
  • Drug: SF Easyhaler
    2 inhalations as a single dose
  • Active Comparator: Seretide Diskus and charcoal
    Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal
    Intervention: Drug: Seretide Diskus and charcoal
  • Active Comparator: Seretide Diskus
    Single-dose of Seretide Diskus (50/500 mcg/inhalation)
    Intervention: Drug: Seretide Diskus
  • Experimental: SF Easyhaler and charcoal
    Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal
    Intervention: Drug: SF Easyhaler and charcoal
  • Experimental: SF Easyhaler
    Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation)
    Intervention: Drug: SF Easyhaler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01766843
3106007, EudraCT 2012-00378-41
No
Orion Corporation, Orion Pharma
Orion Corporation, Orion Pharma
Not Provided
Principal Investigator: Leena Mattila, MD, PhD Orion Corporation, Orion Pharma
Study Director: Maria Sokka IRW Consulting
Orion Corporation, Orion Pharma
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP