Pharmacokinetic study of acetaminophen and ibuprofen oral formulation, in healthy volunteers, fasting conditions
- Conditions
- Pain reliefAnaesthesiology - Pain management
- Registration Number
- ACTRN12616000316404
- Lead Sponsor
- AFT Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Healthy volunteers, 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 for at least 7 days before the start of each study phase, 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 ECG recording), urinalysis, and blood biochemical and haematological examinations.
Pregnancy, nursing, drug abuse, smoking>10 cigarettes per day, alcohol intake, prescription drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine and compare dose-normalized acetaminophen and ibuprofen related pharmacokinetic parameters (Cmax, AUC(0-t), AUC(0-inf), Tmax and t1/2 of acetaminophen and ibuprofen[Single dose study measuring plasma concentrations measured pre-dose and at 10, 20, 30, 45 minutes and 1, 1.25, 1.50, 2,2.5, 3,4,6,8,10 and 12 hours after the study drug administration. ]
- Secondary Outcome Measures
Name Time Method Safety will be evaluated during each study period and for 7 days following study drug administration.<br>An acute safety evaluation will be performed during each study period by recording spontaneously reported adverse events and by clinical assessments. At the end of each study period an additional blood sample will be taken for hematology and biochemistry assessment. Known NSAID adverse effects (i.e. gastrointestinal(GI) ulceration, indigestion, stomach pain, GI bleeding, bronchospasm, water retention, renal failure, skin reactions and thromboembolic events). Known acetaminophen adverse events(i.e. clinical evidence of hepatotoxicity) will be summarized by treatment groups. Adverse events will continue to be assessed up to 7 days after the last dose of the study medication by spontaneous reporting and a final follow-up call[Safety will be evaluated during each study period (from administration to 12 hours post administration) at Days 1, 4, 7 and 14 days following study administration]