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Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus

NCT ID: NCT03060044

Last Updated: 2017-03-03

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-11-30

Brief Summary

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Pharmacokinetic study comparing Salmeterol/fluticasone Easyhaler products and Seretide Diskus 50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in healthy subjects

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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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Salmeterol/fluticasone Easyhaler

single dose of Salmeterol/fluticasone Easyhaler

Group Type EXPERIMENTAL

Salmeterol/fluticasone Easyhaler

Intervention Type DRUG

Salmeterol/fluticasone Easyhaler with charcoal

Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration

Group Type EXPERIMENTAL

Salmeterol/fluticasone Easyhaler with charcoal

Intervention Type DRUG

Seretide Diskus

Single dose of Seretide Diskus

Group Type ACTIVE_COMPARATOR

Seretide Diskus

Intervention Type DRUG

Seretide Diskus with charcoal

Single dose of Seretide Diskus with concomitant charcoal administration

Group Type ACTIVE_COMPARATOR

Seretide Diskus with charcoal

Intervention Type DRUG

Interventions

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Salmeterol/fluticasone Easyhaler

Intervention Type DRUG

Salmeterol/fluticasone Easyhaler with charcoal

Intervention Type DRUG

Seretide Diskus

Intervention Type DRUG

Seretide Diskus with charcoal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* written informed consent obtained
* good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion Criteria

* evidence of a clinically significant cardiovascular, renal, hepatic, hematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
* any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study. as an exception paracetamol and ibuprofen for occasional pain are allowed
* known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) 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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Iissa Kivistö

Role: STUDY_DIRECTOR

Clinical Study director

Locations

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Orion Pharma pharmacology Unit

Espoo, , Finland

Site Status

Countries

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Finland

Other Identifiers

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3106010

Identifier Type: -

Identifier Source: org_study_id

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