Phase I Pharmacokinetic Study (SALBLOCK)
SALBLOCK
Effect of Charcoal on Gastrointestinal Absorption of Salmeterol and Fluticasone Propionate.
1 other identifier
interventional
20
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 27, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJune 26, 2012
March 1, 2012
2 months
March 21, 2012
June 25, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 hours
Secondary Outcomes (1)
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.
24 hours
Study Arms (2)
Treatment A
EXPERIMENTALSalmeterol/fluticasone propionate with concomitant charcoal
Treatment B
EXPERIMENTALSalmeterol/fluticasone propionate without concomitant charcoal
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males and females aged 18-60
- Normal weight at least 50 kg
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CRST (Clinical Research Services Turku)
Turku, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mika Scheinin, MD, PhD
Clinical Research Services Turku Finland
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2012
First Posted
March 27, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 26, 2012
Record last verified: 2012-03