NCT01423305CompletedPhase 1
Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol
Orion Corporation, Orion Pharma1 site in 1 country20 target enrollmentStarted: August 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The evaluation of primary pharmacokinetic variable AUCt
Study Overview
Brief Summary
The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.
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 years.
- •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 clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
- •Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
- •Known hypersensitivity to the active substance(s) or the excipients of the drug.
- •Pregnant or lactating females.
Arms & Interventions
Treatment A
Experimental
Budesonide/formoterol capsule (Orion Pharma) for oral administration.
Intervention: Budesonide/formoterol capsule. (Drug)
Treatment B
Experimental
Budesonide/formoterol capsule (Orion Pharma) for oral administration.
Intervention: Budesonide/formoterol capsule for oral adm. (Drug)
Outcomes
Primary Outcomes
The evaluation of primary pharmacokinetic variable AUCt
Time Frame: 4 weeks
The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design.
Secondary Outcomes
- Pharmacokinetic variables(4 weeks)
- Pharmacokinetic variable(4 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Phase I Pharmacokinetic Study (SALBLOCK)Healthy Volunteer StudyNCT01564199Orion Corporation, Orion Pharma20
Completed
Phase 1
Effect of Charcoal on Gastrointestinal Absorption of TiotropiumHealthy Volunteer StudyNCT03945344Orion Corporation, Orion Pharma20
Unknown
Phase 2
Role of Activated Charcoal in Decreasing Blood Urea, Creatinine and PhosphorousChronic Kidney Disease stage3NCT04311645Assiut University90
Completed
Not Applicable
A verification study of digestion and absorption property of the test foodHealthy Japanese subjectsJPRN-UMIN000045943ORTHOMEDICO Inc.11
Completed
Not Applicable
Effects of CharcoCaps® (Activated Charcoal) vs. Placebo on Intestinal Gas ProductionIntestinal GasNCT05510778University of Memphis20