Phase I Pharmacokinetic Study (SALBLOCK)

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-06-30

Brief Summary

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The objective of the study is to assess the extent to which the charcoal prevents the absorption of salmeterol and fluticasone via the GI tract. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve (AUCt).

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Detailed Description

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Conditions

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Healthy Volunteer Study

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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Treatment A

Salmeterol/fluticasone propionate with concomitant charcoal

Group Type EXPERIMENTAL

salmeterol / fluticasone propionate

Intervention Type DRUG

100/1000 μg oral capsule

Treatment B

Salmeterol/fluticasone propionate without concomitant charcoal

Group Type EXPERIMENTAL

salmeterol / fluticasone propionate

Intervention Type DRUG

100/1000 μg oral capsule

Interventions

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salmeterol / fluticasone propionate

100/1000 μg oral capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males and females aged 18-60
* 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 the interpretation of study result or constitute a health risk for the subject if he/she participates in the study.
* Known hypersensitivity to the active substance(s) or to the excipients of the drug.
* Pregnant or lactating females.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes