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Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

NCT ID: NCT01386996

Last Updated: 2011-12-22

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

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-11-30

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Charcoal and Budesonide/formoterol Easyhaler

Group Type EXPERIMENTAL

Budesonide/formoterol Easyhaler 320/9 microg

Intervention Type DRUG

2 inhalations as a single dose

Charcoal and Symbicort Turbuhaler

Group Type ACTIVE_COMPARATOR

Symbicort Turbuhaler forte

Intervention Type DRUG

2 inhalations as a single dose

Budesonide/formoterol Easyhaler

Group Type EXPERIMENTAL

Budesonide/formoterol Easyhaler 320/9 microg

Intervention Type DRUG

2 inhalations as a single dose

Symbicort Turbuhaler

Group Type ACTIVE_COMPARATOR

Symbicort Turbuhaler forte

Intervention Type DRUG

2 inhalations as a single dose

Interventions

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Budesonide/formoterol Easyhaler 320/9 microg

2 inhalations as a single dose

Intervention Type DRUG

Symbicort Turbuhaler forte

2 inhalations as a single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy males and females aged 18-60 years.
2. Normal weight, at least 50 kg.

Exclusion Criteria

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
4. Known hypersensitivity to the active substance(s) or the excipient of the drug.
5. Pregnant or lactating females.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulla Sairanen, MSc

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Kimmo Ingman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Orion Corporation, Orion Pharma

Locations

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Orion Pharma Phase I Unit

Espoo, , Finland

Site Status

Countries

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Finland

Other Identifiers

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3103004

Identifier Type: -

Identifier Source: org_study_id