Maxigesic PE Study: Determining the bioavailaiblity of Maxigesic PE in healthy adult volunteers.

INTERVENTION: Intervention: Maxigesic PE as a single oral dose of two tablets (total dose paracetamol 1000mg, ibuprofen 150mg and phenylephrine 10mg). Cross‐over study with 7 day washout period between dosing. Note: Maxigesic PE is the brand name of this product. Each tablet of Maxigesic PE contains 500mg paracetamol, 150mg ibuprofen and 5mg phenylephrine. CONDITION: Pharmacokinetics of Maxigesic PE in Healthy Volunteers PRIMARY OUTCOME: To describe the pharmacokinetics of Maxigesic PE and identify whether a pharmacokinetic interaction exists between phenylephrine and paracetamol or ibuprofen when given concomitantly. ; ; This will be assessed by taking blood samples which will be assyed for paracetamol, ibuprofen and phenylephrine concentrations and the pharmacokinetic parameters AUC0‐inf, AUC0‐t, Cmax, Ke, Tmax and T1/2 will be determined. These pharmacokinetic parameters will be compared between groups. SECONDARY OUTCOME: To examine the safety and tolerability of Maxigesic PE. ; ; Safety will be evaluated during each study period, and for 7 days following study drug administration. Acute safety evaluations will be performed during each study period by recording spontaneously reported AE's and by clinical assessments (incl. heamatology & biochemistry). ; ; Known NSAID adverse effects (i.e. GI ulceration, indigestion/stomach pain, GI bleeding, bronchospasm, water retention, renal failure, skin reactions and thromboembolic events), known paracetamol adverse effects (i.e. clinical evidence of hepatotoxicity) and known phenylephrine adverse effects (i.e. bradycardia, hypertension) will be compared between groups. INCLUSION CRITERIA: 1) Provide written informed consent 2) Have Body Mass Index between 18.5 ang 30.0 kg/m2 3) Healty volunteers as determined by medical history, physical examination, ECG, vital signs and laboratory tests