ClinicalTrials.Veeva

Menu

A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets

Bayer logo

Bayer

Status and phase

Completed
Phase 1

Conditions

Moderate Pain

Treatments

Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Drug: 400 mg ibuprofen (Dolormin Extra)
Drug: 400 mg ibuprofen(Nurofen)
Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03225352
19220
2016-004546-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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 design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 4 patient groups

Sequence 1: starting with BAYE4465 500 mg
Experimental group
Description:
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
Treatment:
Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Drug: 400 mg ibuprofen (Dolormin Extra)
Drug: 400 mg ibuprofen(Nurofen)
Sequence 2: starting with BAYE4465 1000 mg
Experimental group
Description:
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
Treatment:
Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Drug: 400 mg ibuprofen (Dolormin Extra)
Drug: 400 mg ibuprofen(Nurofen)
Sequence 3: starting with Nurofen
Experimental group
Description:
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
Treatment:
Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Drug: 400 mg ibuprofen (Dolormin Extra)
Drug: 400 mg ibuprofen(Nurofen)
Sequence 4: starting with Dolormin Extra
Experimental group
Description:
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
Treatment:
Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Drug: 400 mg ibuprofen (Dolormin Extra)
Drug: 400 mg ibuprofen(Nurofen)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems