Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus

September 28, 2015 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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

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, 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

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
  • Masking: NONE

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 (Carbomix granules)
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 (Carbomix granules)
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: within 34 h
within 34 h
AUCt of plasma salmeterol and fluticasone propionate
Time Frame: 34 h
34 h

Collaborators and Investigators

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

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Merja Mäkitalo, Orion Corporation, Orion Pharma
  • Principal Investigator: Leena Mattila, MD, PhD, Orion Pharma Clinical Pharmacology Unit, Espoo, Finland

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

June 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (ESTIMATE)

June 12, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3106009

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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