Trial Condition(s):

Moderate Pain

A study to assess disintegration of the new Aspirin disintegrating tablets

Bayer Identifier:

19220

ClinicalTrials.gov Identifier:

NCT03225352

EudraCT Number:

2016-004546-29

Study Completed

Trial Purpose

The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets

Inclusion Criteria
- Healthy male volunteers aged 18 to 65 years included
- 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
- Blood donation within the last 90 days prior to planned randomization
- 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

Trial Summary

Enrollment Goal
12
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Bio-Images Research Ltd

Glasgow, United Kingdom, G4 0SF

Status
Completed
 

Trial Design