Phase I Pharmacokinetic Study (SALBLOCK)
Information source: Orion Corporation, Orion Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer Study
Intervention: salmeterol / fluticasone propionate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Orion Corporation, Orion Pharma Official(s) and/or principal investigator(s): Mika Scheinin, MD, PhD, Principal Investigator, Affiliation: Clinical Research Services Turku Finland
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).
Clinical Details
Official title: Effect of Charcoal on Gastrointestinal Absorption of Salmeterol and Fluticasone Propionate.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
CRST (Clinical Research Services Turku), Turku, Finland
Additional Information
Starting date: April 2012
Last updated: June 25, 2012
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