Exploratory Phase 1 pharmacokinetic study of different doses of paracetamol plus ibuprofen under fasting and fed conditions
Phase 1
Completed
- Conditions
- Pharmacokinetic studyOther - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12613000887774
- Lead Sponsor
- AFT Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Healthy volunteers.
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.
Exclusion Criteria
pregnancy, nursing, drug abuse, smoking > 10 cigarettes per day, excess alcohol intake, Rx drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests, have any history of allergy or hypersensitivity to ibuprofen, aspirin, paracetamol or other NSAID
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of Pharmacokinetic paramaters [Cmax, AUC, Tmax, T 1/2] of different doses of paracetamol and ibuprofen under fasting and fed conditions.<br><br>[Single dose study measuring plasma concentrations over 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 6, 8, 10 and 12 hours after 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, including measurements of blood pressure and heart rate.<br>At screening and at the end of each study period an additional blood sample will be taken for haematology and biochemistry assessment.<br>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 paracetamol adverse effects (i.e. clinical evidence of hepatotoxicity) will be compared between groups.<br>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.<br>[Safety will be evaluated during each study period, and for 7 days following study drug administration. <br>]