Pharmacokinetic study of two orally formulated combinations of acetaminophen and ibuprofen (Maxigesic Rapid vs Maxigesic 325) in healthy volunteers under fasting conditions

INTERVENTION: Maxigesic® Rapid (Treatment A)‐ Acetaminophen 325 mg and Ibuprofen 97.5mg Single Dose: Oral administration of three film coated tablets with 240 ml of water under fasting conditions (subjects will be fasted‐abstain from all liquids and food except water for at least 10 hours overnight before dosing and for 4 hours after dosing) The dose will be taken under the supervision of the site study staff and the dosing time will be recorded on the site source document The washout period is at least 3 days between the two treatment periods. CONDITION: Pain relief PRIMARY OUTCOME: To evaluate and compare the pharmacokinetic parameters (Cmax, AUC0‐t, AUC0‐inf, Tmax, Kel and t1/2el) between test and reference products under fasting conditions SECONDARY OUTCOME: To compare the safety and tolerability of test and reference products under fasting conditions. ; An acute safety evaluation will be performed during each study period by recording spontaneously reported adverse events and by clinical assessments, including measurements of vital signs (blood pressure, heart rate, respiratory rate) and body temperature. ; These measurements will be done at screening as well as prior, during and after each dosing period. ; Vital signs will be measured pre‐dose and approximately at 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00 and 12.00 hours after study drug administration. Body temperature will be measured before dosing and approximately at the following times after dosing: 4th and 12th hour. Vital signs may be taken at other times if deemed necessary. ; At screening and at the end of each study period an additional blood sample will be taken for haematology, biochemistry and serological assessment (only in screening). ; Known NSAID adverse effects (i.e. GI ulceration, indigestion/stomach pain, GI bleeding, bronchospasm, water retention, renal failure, skin reactions and thromboembolic events), and known adverse effects of acetaminophen (i.e. clinical evidence of hepatotoxicity) will be compared between groups. ; Adverse events will continue to be assessed up to 7 days after the last dose of the study medication by spontaneous reporting and at a final follow‐up phone call. INCLUSION CRITERIA: Healthy subjects, males and females aged 18 to 50 years of age. Females must be sterile or using adequate contraception. Participants must not have taken any prescription medications for at least 14 days or over‐the‐counter medications and herbal remedies for at least 7 days before the start of each study phase and for the duration of the study, with the exception of oral contraceptives and the study medication. All subjects must be deemed healthy on the basis of a medical history, physical exam (including vital signs and 12‐lead ECG recording), urinalysis, and blood biochemical, serological and haematological examinations.