Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus

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

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-09-30

Brief Summary

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The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream

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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 (Carbomix granules)

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 (Carbomix granules)

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, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
* Any condition requiring regular 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