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

January 2, 2014 updated by: Orion Corporation, Orion Pharma

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Espoo, Finland
        • Orion Pharma Clinical Pharmacology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Seretide Diskus and charcoal
Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal
2 inhalations as a single dose
Active Comparator: Seretide Diskus
Single-dose of Seretide Diskus (50/500 mcg/inhalation)
2 inhalations as a single dose
Experimental: SF Easyhaler and charcoal
Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal
2 inhalations as a single dose
Experimental: SF Easyhaler
Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation)
2 inhalations as a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameter Cmax of plasma salmeterol concentration
Time Frame: Within 34 h
Within 34 h
Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration
Time Frame: Within 34 h
Within 34 h
Pharmacokinetic parameter AUCt of plasma salmeterol concentration
Time Frame: within 34 h
within 34 h
Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration
Time Frame: within 34 h
within 34 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Leena Mattila, MD, PhD, Orion Corporation, Orion Pharma
  • Study Director: Maria Sokka, IRW Consulting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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