Effect of Charcoal on Gastrointestinal Absorption of Tiotropium
NCT ID: NCT03945344
Last Updated: 2019-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2019-05-27
2019-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment A
Tiotropium with concomitant charcoal
Tiotropium
Oral capsule 20 μg
Treatment B
Tiotropium without concomitant charcoal.
Tiotropium
Oral capsule 20 μg
Interventions
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Tiotropium
Oral capsule 20 μg
Tiotropium
Oral capsule 20 μg
Eligibility Criteria
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Inclusion Criteria
2. Healthy males and females, aged 18-60
3. Normal weight at least 50 kg.
Exclusion Criteria
2. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
3. 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.
4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug.
5. Pregnant or lactating females.
6. Females of childbearing potential not using proper contraception.
18 Years
60 Years
ALL
Yes
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Maria Annunen, MSc
Role: STUDY_DIRECTOR
Orion Corporation, Orion Pharma
Locations
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Clinical Pharmacology Unit
Espoo, , Finland
Countries
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Other Identifiers
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3122003
Identifier Type: -
Identifier Source: org_study_id
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