Pharmacokinetic Pilot Study on Budesonide/Formoterol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Inhaler device

Intervention Type DEVICE

Turbohaler Forte

Inhaler device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes