Effect of Charcoal on Gastrointestinal Absorption of Salmeterol and Fluticasone Propionate.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Treatment B
Salmeterol/fluticasone propionate without concomitant charcoal
Intervention: salmeterol / fluticasone propionate (Drug)
Treatment A
Salmeterol/fluticasone propionate with concomitant charcoal
Intervention: salmeterol / fluticasone propionate (Drug)
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.
Time Frame: 24 hours
The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover study design.
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.(24 hours)