Topic: Gastroenterology
Conditions
Interventions
Study Visit 1: Participants will be randomised to either:
1. Swallow an aspirin with the SMART Swallowing Aid
2. Swallow an aspirin with water
Study Vi
Sponsors
Norfolk and Norwich University Hospital NHS Trust (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy 2. Male 3. Age 18 to 35 years
Exclusion criteria
Exclusion criteria: 1. Participants who are studying at the UEA School of Pharmacy or School of Medicine 2. Participants who don?t eat or are allergic to gelatin, HPMC, citric acid or potassium sorbate 3. Participants who are lactose intolerant or suffer with celiac disease 4. Patients who suffer from dysphagia or have difficulty swallowing 5. Participants who are allergic to aspirin or any other NSAID 6. Participants with hypersensitivity to aspirin i.e. attacks of asthma, angioedema, urticaria or rhinitis precipitated by aspirin or any other NSAID 7. Participants who have active peptic ulceration 8. Participants who have haemophilia or other bleeding disorders 9. Participants taking aspirin regularly or who have taken aspirin in the last 7 days 10. Participants who are taking other medications, particularly those containing salicylates 11. Patients with parallel participation in another research study 12. Any person related to or living with any member of the study team 13. Any person with language difficulties
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence of aspirin with and without SMART Swallowing Aid; primary outcome measures: platelet function and salicylate assay The primary outcome, of aspirin blood concentration, is measured in the blood samples which will be taken at time zero then 20, 40, 60, 90 and 120 minutes after the aspirin has been swallowed. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome aims to determine if the gel is easy and comfortable to swallow in comparison with the tablet administered with water. This is measured by a brief questionnaire which is completed after the aspirin has been swallowed. | — |
Countries
United Kingdom
Outcome results
None listed