Healthy Volunteer Study
Conditions
Brief summary
The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol formulations.
Interventions
DRUGIbuprofen Acid
DRUGIbuprofen Lysine
DRUGIbuprofen Sodium
DRUGIbuprofen Liquid Capsules
DRUGParacetamol
Sponsors
Simbec Research
Reckitt Benckiser Healthcare (UK) Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: \> 18 to \< 50 years. 2. Sex: Male and female subjects are eligible for entry. 3. Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception, if applicable 4. Female subject of non-child bearing potential with negative pregnancy test at the screening visit. 5. Male subject willing to use an effective method of contraception. 6. Status: Healthy volunteers with a body mass index of \>18 and \<30 kg/m2. 7. Absence of relevant abnormalities in the clinical examination, ECG, drug and safety analysis. 8. Subjects who have given written informed consent
Exclusion criteria
1. Pregnant or lactating female subjects. 2. A history of significant disease of any body-system. 3. Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs. 4. A history of allergy or intolerance (including angio-oedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, or the excipients of the formulations. 5. A history of peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders. 6. A history of frequent dyspepsia, e.g., heartburn or indigestion. 7. A history of migraine. 8. A history of psychotic illness, attempted suicide or parasuicide. 9. Current smokers and ex-smokers who have smoked within 6 months. 10. A history of drug abuse (including alcohol). 11. High consumption of stimulating drinks 12. Those with positive drugs of abuse screen including alcohol on any occasion throughout the study. 13. 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). 14. 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. 15. Donation of blood in quantity in the previous 12 weeks before enrolment into the study 16. Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen. 17. Topical use of ibuprofen within 7 days before dosing with study medication 18. Those previously randomised into this study. 19. Employee at study site. 20. Partner or first degree relative of the investigator. 21. Those with an ibuprofen level \> 10 ng/ml as determined at pre-study screening visit 2 (Part 2 (Pivotal Phase) of the study only). 22. Those who are unwilling to consume gelatin of animal origin (Part 2 (Pivotal Phase) of the study only). 23. Those who have participated in a clinical trial in the previous 12 weeks 24. Those unable in the opinion of the Investigator to comply fully with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the maximum concentration (Cmax) of the reference Ibuprofen | 0-4hr |
| Time to the first extrapolated non-zero concentration (Tlag) | 0-4hr |
| Time to the maximum concentration (Tmax) | 0-4hr |
Secondary
| Measure | Time frame |
|---|---|
| Partial area under the curve (AUCs) at each nominal blood sampling time-point | 0-4hr |
| The area under the curve up to the median Tmax for the ibuprofen reference product (AUCTmaxRef) | 0-4hr |
| Time to the lower therapeutic level reaching at least 5 µg/ml (T5.0) for ibuprofen and paracetamol | 0-4hr |
| The maximum plasma concentration (Cmax) | 0-4hr |
| The plasma concentration at each planned nominal time-point (Cn) | 0-4hr |
| Time to the mid therapeutic level reaching at least 8.4 µg/ml (T8.4) for ibuprofen and 10 µg/ml (T10.0) for paracetamol | 0-4hr |
| Time to the higher therapeutic level reaching at least 10.0 µg/ml (T10.0) for ibuprofen and 20 µg/ml (T20.0) for paracetamol | 0-4hr |
Outcome results
None listed