Nurofen Ibuprofen Orodispersible Tablet Disintegration Study

Launched by RECKITT BENCKISER HEALTHCARE (UK) LIMITED · Aug 31, 2018

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects who have given written informed consent.
• • 2. Age: ≥ 18 years ≤ 50 years.
• • 3. Body Mass Index (BMI) of ≥ 18.5 and ≤ 30 kg/m2.
• • 4. Healthy as determined by past medical history, physical examination and vital signs at screening.
• Exclusion Criteria:
• • 1. A history of allergy or intolerance (including angioedema, urticaria, bronchospasm, reflux symptoms and rhinitis) related to treatment with ibuprofen, aspirin or other NSAIDs, or the excipients of the formulations.
• • 2. A history (treated or untreated) of an oral condition affecting salivation and mouth dryness (e.g. dry mouth, hypersalivation)
• • 3. A history of hepatic or renal impairment, hepatic dysfunction, cardiovascular disease, cerebrovascular problems or high blood pressure.
• • 4. A history of asthma.
• • 5. A history of peptic or duodenal ulcers or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders (including gastro-oesophageal reflux symptoms or gastritis) ulceration, perforation or haemorrhage.
• • 6. A history of coagulation disorder or susceptibility to bleeding
• • 7. A current or recent (within 2 months) oral issue, which in the opinion of the Principal Investigator could interfere with the study (e.g. mouth ulcers, aphthous ulcers, herpetic disease, oral candidiasis, burning mouth syndrome, geographic tongue, oral swellings, sores or lesions.
• • 8. Those currently suffering from dehydration
• • 9. A current or history of oral piercing.
• • 10. A current or recent history (within one year of the study) of alcohol abuse or significant abuse/misuse of any legal or illegal drugs, substances and solvents
• • 11. Those with a positive screen/test for drugs of abuse and/or alcohol
• • 12. Those who consume more than 14 units of alcohol per week, and where this consumption is spread over less than 3 days, or those who regularly (weekly) consumed excessive amounts of alcohol (\>8 units for men and \>6 units for women in one consumption, excessive amounts as defined by the UK National Office of Statistics)
• • 13. Those who had consumed alcohol within the 24 hours before enrolment onto the study.
• • 14. Those who had regularly consumed excessive quantities of caffeine (\>6 cups of tea, coffee or cola per day), according to the Investigator's judgment.
• • 15. Those who had consumed caffeine-containing food and drinks within the 24 hours before enrolment onto the study.
• • 16. Those who had performed strenuous exercise within the 24 hours before enrolment onto the study.
• • 17. Those who currently or have recently (within last 6 months) use/d tobacco or nicotine containing products.
• • 18. Those who have used any herbal/vitamin or fish oil supplement in the 7 days prior to enrolment
• • 19. Those who have used any OTC or prescription medications (except hormonal contraceptives) in the 7 days prior to enrolment
• • 20. Those who have used ibuprofen with concomitant aspirin or other NSAIDs including cyclooxygenase-2 selective inhibitors and any drugs that should be used with caution, in combination with ibuprofen as per the SmPC, in the 7 days prior to enrolment (or longer if stated within the SmPC)
• • 21. Those previously randomised into this study.
• • 22. Those who are an employee at the study site.
• • 23. Those who are a partner or first-degree relative of the Investigator or other employees.
• • 24. Those who have participated in any taste testing study within 3 days of the screening visit.
• • 25. Those who have participated in a clinical trial involving consumption of an investigational medicinal product within 3 months of dosing or a study with a marketed compound in the last month before dosing.
• • 26. Those unable in the opinion of the Investigator to comply fully with the study requirements.
• • 27. Women who are pregnant or breast feeding