Bioequivalence study Not Applicable
Conditions
Interventions
Each volunteer will be administered an aspirin tablet both with and without the gel swallowing aid on two separate occasions. Six blood samples will be taken over the course of two hours on each occas
Sponsors
Norfolk and Norwich University Hospital NHS Trust (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy male volunteers aged 18 to 35
Exclusion criteria
Exclusion criteria: 1. Participants who don?t eat or are allergic to gelatin, hydroxypropyl methylcellulose (HPMC), citric acid or potassium sorbate 2. Patients who suffer with dysphagia or difficulty swallowing 3. Participants who are allergic to aspirin or any other Nonsteroidal anti-inflammatory drugs (NSAIDs) 4. Participants with hypersensitivity to aspirin i.e. attacks of asthma, angioedema, urticaria or rhinitis precipitated by aspirin or any other NSAID 5. Participants who have active peptic ulceration. 6. Participants who have haemophilia or other bleeding disorders 7. Participants taking aspirin regularly or who have taken in the last 7 days 8. Participants who are taking other medications, particularly those containing salicylates 9. Patients with parallel participation in another research study 10. Any person related to or living with any member of the study team 11. Any person with language difficulties
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the gel i.e. ?to ensure the gel can be administered safely without unacceptable adverse effects?. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the acceptability of the gel swallowing aid using a questionnaire relating to ease and comfort of swallowing the tablet with and without the gel. | — |
Countries
United Kingdom
Outcome results
None listed