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Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus

NCT ID: NCT01766843

Last Updated: 2014-01-03

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Seretide Diskus and charcoal

Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal

Group Type ACTIVE_COMPARATOR

Seretide Diskus and charcoal

Intervention Type DRUG

2 inhalations as a single dose

Seretide Diskus

Single-dose of Seretide Diskus (50/500 mcg/inhalation)

Group Type ACTIVE_COMPARATOR

Seretide Diskus

Intervention Type DRUG

2 inhalations as a single dose

SF Easyhaler and charcoal

Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal

Group Type EXPERIMENTAL

SF Easyhaler and charcoal

Intervention Type DRUG

2 inhalations as a single dose

SF Easyhaler

Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation)

Group Type EXPERIMENTAL

SF Easyhaler

Intervention Type DRUG

2 inhalations as a single dose

Interventions

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Seretide Diskus and charcoal

2 inhalations as a single dose

Intervention Type DRUG

Seretide Diskus

2 inhalations as a single dose

Intervention Type DRUG

SF Easyhaler and charcoal

2 inhalations as a single dose

Intervention Type DRUG

SF Easyhaler

2 inhalations as a single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
* 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.
* Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
* Known hypersensitivity to the active substance(s) or the excipient of the drug.
* 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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Leena Mattila, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Orion Corporation, Orion Pharma

Maria Sokka

Role: STUDY_DIRECTOR

IRW Consulting

Locations

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Orion Pharma Clinical Pharmacology Unit

Espoo, , Finland

Site Status

Countries

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Finland

Other Identifiers

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3106007, EudraCT 2012-00378-41

Identifier Type: -

Identifier Source: org_study_id

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