Phase I Pharmacokinetic study evaluating the pharmacokinetic profile of a fixed dose combination product (1000 mg paracetamol + 300 mg ibuprofen) under fasting and fed conditions

This study is a Phase I, single-center, single-dose, open-label, randomized, four way cross-over trial in 28 healthy adult participants. After an initial Screening Period, within 14 days of randomization, there will be four Study Periods each separated by a Washout Period of 7 days and a subsequent 7 days of final Follow-up Period, after the completion of the 4 study periods The main objectives of the study are: - to evaluate the pharmacokinetic parameters (Cmax, AUCtot, Tmax and t1/2) of 1000 mg paracetamol and 300 mg ibuprofen, when taken alone, or when taken in combination as 2 tablets of under fasting conditions and - to describe the effect of food on the pharmacokinetic profile of the combination when taken as two tablets (paracetamol 1000 mg + ibuprofen 300 mg). All study medications (paracetamol 1000 mg, ibuprofen 300 mg and their combination) will be administered orally. 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