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Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162485
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Tracking Information
First Submitted Date  ICMJE June 5, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date September 29, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • Cmax of plasma salmeterol and fluticasone propionate [ Time Frame: within 34 h ]
  • AUCt of plasma salmeterol and fluticasone propionate [ Time Frame: 34 h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus
Official Title  ICMJE 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
Brief Summary The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Salmeterol/fluticasone Easyhaler
  • Drug: Salmeterol/fluticasone Easyhaler with charcoal
  • Drug: Seretide Diskus
  • Drug: Seretide Diskus with charcoal
Study Arms  ICMJE
  • Experimental: Salmeterol/fluticasone Easyhaler
    Single dose of Salmeterol/fluticasone Easyhaler
    Intervention: Drug: Salmeterol/fluticasone Easyhaler
  • Experimental: Salmeterol/fluticasone Easyhaler with charcoal
    Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration (Carbomix granules)
    Intervention: Drug: Salmeterol/fluticasone Easyhaler with charcoal
  • Active Comparator: Seretide Diskus
    Single dose of Seretide Diskus
    Intervention: Drug: Seretide Diskus
  • Active Comparator: Seretide Diskus with charcoal
    Single dose of Seretide Diskus with concomitant charcoal administration (Carbomix granules)
    Intervention: Drug: Seretide Diskus with charcoal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2015)
129
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
128
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
  • Any condition requiring regular 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162485
Other Study ID Numbers  ICMJE 3106009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orion Corporation, Orion Pharma
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Merja Mäkitalo Orion Corporation, Orion Pharma
Principal Investigator: Leena Mattila, MD, PhD Orion Pharma Clinical Pharmacology Unit, Espoo, Finland
PRS Account Orion Corporation, Orion Pharma
Verification Date September 2015

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