Phase I Pharmacokinetic Study (SALBLOCK)

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Charcoal; Fluticasone; Salmeterol Xinafoate; Xhance

Criteria

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.