A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets

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)