Phase I Pharmacokinetic Study (SALBLOCK)

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: salmeterol / fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01564199

3106006

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Treatment A

Experimental group

Description:

Salmeterol/fluticasone propionate with concomitant charcoal

Treatment:

Drug: salmeterol / fluticasone propionate

Treatment B

Experimental group

Description:

Salmeterol/fluticasone propionate without concomitant charcoal

Treatment:

Drug: salmeterol / fluticasone propionate