NCT01457716

Brief Summary

The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

1 month

First QC Date

September 28, 2011

Last Update Submit

February 2, 2012

Conditions

Healthy

Keywords

Healthy volunteer study

Outcome Measures

Primary Outcomes (2)

  • Cmax of Budesonide and Formoterol

    24 hours

  • AUCt of Budesonide and Formoterol

    24 hours

Secondary Outcomes (3)

  • AUCinf of Budesonide and Formoterol

    24 hours

  • tmax of Budesonide and Formoterol

    24 hours

  • t1/2 of Budesonide and Formoterol

    24 hours

Study Arms (4)

Budesonide/Formoterol Easyhaler A

EXPERIMENTAL
Drug: BudesonideDrug: FormoterolDevice: Easyhaler

Budesonide/Formoterol Easyhaler B

EXPERIMENTAL
Drug: BudesonideDrug: FormoterolDevice: Easyhaler

Budesonide/Formoterol Easyhaler C

EXPERIMENTAL
Drug: BudesonideDrug: FormoterolDevice: Easyhaler

Budesonide/Formoterol Turbohaler Forte

ACTIVE COMPARATOR
Drug: BudesonideDrug: FormoterolDevice: Turbohaler Forte

Interventions

BudesonideDRUG

Single inhalation

Budesonide/Formoterol Easyhaler ABudesonide/Formoterol Easyhaler BBudesonide/Formoterol Easyhaler CBudesonide/Formoterol Turbohaler Forte
FormoterolDRUG

Single inhalation

Budesonide/Formoterol Easyhaler ABudesonide/Formoterol Easyhaler BBudesonide/Formoterol Easyhaler CBudesonide/Formoterol Turbohaler Forte
EasyhalerDEVICE

Inhaler device

Budesonide/Formoterol Easyhaler ABudesonide/Formoterol Easyhaler BBudesonide/Formoterol Easyhaler C
Turbohaler ForteDEVICE

Inhaler device

Budesonide/Formoterol Turbohaler Forte

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females, 18-55 years of age.
  • Normal weight at least 50 kg.

You may not qualify if:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
  • Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
  • Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
  • Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
  • Pregnant or lactating females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel International GmbH

Berlin, Germany

Location

MeSH Terms

Interventions

BudesonideFormoterol Fumarate

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Johanna Hietamäki, MSc

    Orion Corporation, Orion Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2011

First Posted

October 24, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

February 3, 2012

Record last verified: 2012-02

Locations

DE(1)