A Randomized, Open label, Single Center, Single Oral Dose, Four Treatment, Four Period, Four Sequence, Crossover Bioavailability Study of Haleon Immediate Release Tablets 2X (paracetamol/naproxen 500 mg/125 mg) vs. Panadol Advance Tablets 2X (paracetamol 500 mg), Naprosyn Tablets 1X (naproxen 250 mg), administered individually in fasted conditions and Haleon Immediate Release Tablets 2X (paracetamol/naproxen 500 mg/125 mg) in fed conditions in Healthy Adult Participants

Condition studied

Healthy volunteers, therapeutic indication not studied

Investigational medicinal product(s)

Eligibility

Primary endpoint

AUC0-tlast, Cmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively

Endpoint detail

AUC0-tlast, Cmax and tmax for paracetamol and naproxen after administration of Test under fasted vs. Test under fed conditions, Tmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol after fasted administration of Reference 1, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for naproxen after fasted administration of Reference 2, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol and naproxen after administration of Test, under fasted and fed condition, Tolerability assessment based on AEs, vital signs and protocol-specified safety labs for Test and Reference treatments.