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
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Seretide Diskus and charcoal
Drug: Seretide Diskus
Drug: SF Easyhaler and charcoal
Drug: SF Easyhaler
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: January 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Seretide Diskus and charcoal
Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal
Drug: Seretide Diskus and charcoal
2 inhalations as a single dose
Active Comparator: Seretide Diskus
Single-dose of Seretide Diskus (50/500 mcg/inhalation)
Drug: Seretide Diskus
2 inhalations as a single dose
Experimental: SF Easyhaler and charcoal
Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal
Drug: SF Easyhaler and charcoal
2 inhalations as a single dose
Experimental: SF Easyhaler
Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation)
Drug: SF Easyhaler
2 inhalations as a single dose

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766843

Locations
Finland
Orion Pharma Clinical Pharmacology Unit
Espoo, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Leena Mattila, MD, PhD Orion Corporation, Orion Pharma
Study Director: Maria Sokka IRW Consulting
  More Information

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01766843     History of Changes
Other Study ID Numbers: 3106007, EudraCT 2012-00378-41
Study First Received: January 9, 2013
Last Updated: January 2, 2014
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Fluticasone
Salmeterol
Charcoal
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on October 16, 2014