Phase I Pharmacokinetic Study (SALBLOCK)

Orion Corporation, Orion Pharma20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Study

Interventions

salmeterol / fluticasone propionateDRUG

100/1000 μg oral capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CRST (Clinical Research Services Turku)

Turku, Finland

Outcomes

Primary Outcomes

The pharmacokinetic parameter Area Under Curve (AUC) time frame: predose and 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 hours post-dose.

The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover study design.

Time frame: 24 hours

Secondary Outcomes

The pharmacokinetic variables Cmax and tmax time frame: predose and 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 hours post-dose.

Time frame: 24 hours

Data from ClinicalTrials.gov

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