A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets
NCT ID: NCT03225352
Last Updated: 2018-06-06
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
12 participants
INTERVENTIONAL
2017-08-07
2017-10-16
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
OTHER
NONE
Study Groups
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Sequence 1: starting with BAYE4465 500 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 500mg
1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 1000mg
400 mg ibuprofen(Nurofen)
Single intake of 1 tablet, 400mg
400 mg ibuprofen (Dolormin Extra)
Single intake of 1 tablet, 400mg
Sequence 2: starting with BAYE4465 1000 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 500mg
1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 1000mg
400 mg ibuprofen(Nurofen)
Single intake of 1 tablet, 400mg
400 mg ibuprofen (Dolormin Extra)
Single intake of 1 tablet, 400mg
Sequence 3: starting with Nurofen
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 500mg
1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 1000mg
400 mg ibuprofen(Nurofen)
Single intake of 1 tablet, 400mg
400 mg ibuprofen (Dolormin Extra)
Single intake of 1 tablet, 400mg
Sequence 4: starting with Dolormin Extra
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 500mg
1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 1000mg
400 mg ibuprofen(Nurofen)
Single intake of 1 tablet, 400mg
400 mg ibuprofen (Dolormin Extra)
Single intake of 1 tablet, 400mg
Interventions
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500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 500mg
1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 1000mg
400 mg ibuprofen(Nurofen)
Single intake of 1 tablet, 400mg
400 mg ibuprofen (Dolormin Extra)
Single intake of 1 tablet, 400mg
Eligibility Criteria
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Inclusion Criteria
* Verified diagnosis of "healthy"
* Non-smokers or passive smokers
* BMI in the range of 18.5 to 30 kg/m2
* Subject has given written informed consent to participate in the trial prior to admission to the trial
Exclusion Criteria
* Any previous medication within 10 days before the planned administration of the radiolabelled Investigational Medicinal Product (rIMP) which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety
* Subject has any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area which, in the opinion of the physician responsible, could affect the study conduct.
* Vegetarian
* Subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 Millisievert), or will exceed 10 Millisievert over any three year period
18 Years
65 Years
MALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Bio-Images Research Ltd
Glasgow, Glasgow City, United Kingdom
Countries
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Other Identifiers
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2016-004546-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19220
Identifier Type: -
Identifier Source: org_study_id
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