Exploratory Phase 1 pharmacokinetic study of different doses of paracetamol plus ibuprofen under fasting and fed conditions

To evaluate the pharmacokinetic parameters of different fixed dose combinations, under fasting conditions as follows: - paracetamol 325 mg + ibuprofen 97.5 mg - - paracetamol 650 mg + ibuprofen 195 mg - paracetamol 975 mg + ibuprofen 292.5 mg To describe the effect of food on the pharmacokinetic profile of paracetamol 975 mg + ibuprofen 292.5 mg All drugs are administered orally, as single doses. To evaluate safety and tolerability of the different doses of paracetamol and ibuprofen under fasting and fed conditions. There will be a washout period of 7 days from the completion of dosing in one period to the start of the dosing in the next period. Participants will be fasted for at least 10 hours overnight before dosing and for 4 hours post dosing. Participants will be provided with standard meals from 4 hours post dose. Drug assays will be carried out using validated chromatographic methods developed specifically for the determination of paracetamol and ibuprofen. Participants allocated to receive the treatment under fed conditions will receive 30 minutes before the administration of the study drug a standardised high-fat, high-calorie meal. No additional food will be allowed for at least 4 hours after dosing