Gamma Scintigraphy Study to Investigate Tablet Disintegration in Healthy Volunteers.

• Status: Terminated
• Trial end date: 2015-07-30
• Target enrollment: 0
• Participant gender: Male

Summary

The study will be an adaptive, 2 part, single dose, 5-way crossover gamma scintigraphy study in healthy subjects, to investigate the rate and site of tablet disintegration of various forms of Ibuprofen.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

1. Age: > 18 to < 50 years.

2. Sex: Male.

3. Status: Healthy volunteers.

Exclusion Criteria:

1. A history of significant disease of any body-system.

2. Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.

3. A history of allergy or intolerance (including angio-oedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) or the excipients of the formulations.

4. A history of peptic or duodenal ulcers or gastro-intestinal bleed or upper gastrointestinal bleed, or other significant gastro-intestinal disorders.

5. A history of frequent dyspepsia, e.g., heartburn or indigestion.

6. A history of migraine.

7. A history of psychotic illness, attempted suicide or parasuicide.

8. Current smokers and ex-smokers who have smoked within 6 months.

9. A history of drug abuse (including alcohol).

10. High consumption of stimulating drinks (coffee, tea, cola, energy drinks etc.; total caffeine intake per day above 300 mg (1 cup of coffee equates to 50 mg).

11. Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.

12. Ingestion of a prescribed drug at any time in the 14 days before dosing with study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers during the previous month (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).

13. Ingestion of an over-the-counter preparation within 7 days before dosing with study medication, including herbal medications, vitamin/fish oil supplements, ibuprofen and other NSAIDs and paracetamol.

14. Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.

15. Those unable in the opinion of the Investigator to comply fully with the study requirements.

16. Those who are unwilling to consume gelatin of animal origin.

17. Those previously randomised into this study.

18. Employee at study site.

19. Partner or first degree relative of the investigator

20. Those who have participated in a clinical trial in the previous 12 weeks.

21. Participation in a study in which radioisotopes were administered or in which subjects were exposed to any radiation (e.g. x-rays, handling of radiolabelled materials) other than normal background radiation within the 12 months before the screening visit.