Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus

March 2, 2017 updated by: Orion Corporation, Orion Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

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

  • Finland
      • Espoo, Finland
        • Orion Pharma 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:

  • 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, hematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
  • any condition requiring 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Salmeterol/fluticasone Easyhaler
single dose of Salmeterol/fluticasone Easyhaler
Drug: Salmeterol/fluticasone Easyhaler
Experimental: Salmeterol/fluticasone Easyhaler with charcoal
Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration
Drug: Salmeterol/fluticasone Easyhaler with charcoal
Active Comparator: Seretide Diskus
Single dose of Seretide Diskus
Drug: Seretide Diskus
Active Comparator: Seretide Diskus with charcoal
Single dose of Seretide Diskus with concomitant charcoal administration
Drug: Seretide Diskus with charcoal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of plasma salmeterol and fluticasone propionate
Time Frame: 0 hour to 34 hours after study treatment administration
0 hour to 34 hours after study treatment administration
AUCt of plasma salmeterol and fluticasone propionate
Time Frame: 0 hour to 34 hours after study treatment administration
0 hour to 34 hours after study treatment administration

Collaborators and Investigators

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

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Iissa Kivistö, Clinical Study director

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 (Actual)

July 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 17, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3106010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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