A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets

NCT03225352 | Completed Phase 1

• 2 other identifiers: 192202016-004546-29
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Moderate Pain

Outcome Measures

Primary Outcomes (1)

• Time to complete tablet disintegration

  The tablet is radiolabeled. Scintigraphy images of the abdominal area will be taken It is time until an image with no definable hot spot remaining is identified

  Up to 4 hours

Secondary Outcomes (15)

• Gastric empty time, if applicable

  Up to 4 hours

• Time of colon arrival, if applicable

  Up to 4 hours

• Small intestine transit time, if applicable

  Up to 4 hours

• Time of onset of release of radiolabel

  Up to 4 hours

• Site of onset of release of radiolabel

  Up to 4 hours

Study Arms (4)

Sequence 1: starting with BAYE4465 500 mg

EXPERIMENTAL

Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design

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

Sequence 2: starting with BAYE4465 1000 mg

EXPERIMENTAL

Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design

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

Sequence 3: starting with Nurofen

EXPERIMENTAL

Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design

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

Sequence 4: starting with Dolormin Extra

EXPERIMENTAL

Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design

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

Interventions

500 mg acetylsalicylic acid (Aspirin, BAYE4465) DRUG

Single intake of 1 tablet, 500mg

Sequence 1: starting with BAYE4465 500 mg; Sequence 2: starting with BAYE4465 1000 mg; Sequence 3: starting with Nurofen; Sequence 4: starting with Dolormin Extra

1000 mg acetylsalicylic acid (Aspirin, BAYE4465) DRUG

Single intake of 1 tablet, 1000mg

Sequence 1: starting with BAYE4465 500 mg; Sequence 2: starting with BAYE4465 1000 mg; Sequence 3: starting with Nurofen; Sequence 4: starting with Dolormin Extra

400 mg ibuprofen(Nurofen) DRUG

Single intake of 1 tablet, 400mg

Sequence 1: starting with BAYE4465 500 mg; Sequence 2: starting with BAYE4465 1000 mg; Sequence 3: starting with Nurofen; Sequence 4: starting with Dolormin Extra

400 mg ibuprofen (Dolormin Extra) DRUG

Single intake of 1 tablet, 400mg

Sequence 1: starting with BAYE4465 500 mg; Sequence 2: starting with BAYE4465 1000 mg; Sequence 3: starting with Nurofen; Sequence 4: starting with Dolormin Extra

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bio-Images Research Ltd

Glasgow, Glasgow City, G4 0SF, United Kingdom

Location

MeSH Terms

Interventions

Aspirin; Ibuprofen

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: July 21, 2017
• Study Start: August 7, 2017
• Primary Completion: October 7, 2017
• Study Completion: October 16, 2017
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

GB (1)