Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

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

Pharmacokinetic Pilot Study Comparing Three Formulations of Budesonide/Formoterol Easyhaler 160/4.5 Microg/Inhalation and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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, 02100
        • 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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent obtained
  • Body mass index > 19 and < 30kg/m2, weight at least 50 kg
  • 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
  • Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during a study.
  • Known hypersensitivity to the active substance(s) or the excipient of the drug
  • Pregnant and 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: Charcoal and Budesonide/formoterol Easyhaler A
160/4.5microg/inhalation Charcoal
Drug: Budesonide/formoterol
2 inhalations as a single dose
Other Names:
  • Budesonide/formoterol 160/4.5microg
Other: Charcoal
EXPERIMENTAL: Charcoal and Budesonide/formoterol Easyhaler B
160/4.5microg/inhalation Charcoal
Drug: Budesonide/formoterol
2 inhalations as a single dose
Other Names:
  • Budesonide/formoterol 160/4.5microg
Other: Charcoal
EXPERIMENTAL: Charcoal and Budesonide/formoterol Easyhaler C
160/4.5microg/inhalation Charcoal
Drug: Budesonide/formoterol
2 inhalations as a single dose
Other Names:
  • Budesonide/formoterol 160/4.5microg
Other: Charcoal
ACTIVE_COMPARATOR: Charcoal and Symbicort Turbuhaler
160/4.5microg/inhalation Charcoal
Other: Charcoal
Drug: Symbicort Turbuhaler
2 inhalations as a single dose
Other Names:
  • Symbicort Turbuhaler 160/4.5 microg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of plasma budesonide and formoterol
Time Frame: within 24 hours
within 24 hours
AUCt of plasma budesonide and formoterol
Time Frame: within 24 hours
within 24 hours

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 Kivisto, Orion Corporation, Orion Pharma
  • Principal Investigator: Leena Mattila, MD, 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 (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

March 2, 2017

First Posted (ACTUAL)

March 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3103014

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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