A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets

• Status: Completed
• Trial end date: 2017-10-16
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Aspirin; Ibuprofen

Criteria

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