Maxigesic Metabolism Study: To describe the metabolism of paracetamol when combined with ibuprofen in healthy adult volunteers.
- Conditions
- Pharmacokinetics of Maxigesic in Healthy Volunteers.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12612000871842
- Lead Sponsor
- AFT Pharmacetuicals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
1) Provide written informed consent
2) Have Body Mass Index between 18.5 and 30.0 kg/m2
3) Healthy volunteers as determined by medical history, physical examination, ECG, vital signs and laboratory tests
1) Women who are pregnant or nursing
2) Women who are unwilling to take adequate contraceptive precaustions or who are unwilling to undergo urine pregnancy testing
3) History of alcohol or drug abuse or dependency
4) Have a history of allergy or hypersensitivity to ibuprofen, aspirin, any other NSAID or paracetamol
5) Have haemopoetic, renal or hepatic disease, immunosupression. Have a history of gastric ulceration, indigestion, stomach pain, GI bleeding or bleeding disorders. Are currently suffering from dehydration from diarrhoea and/or vomiting. Have a history of severe asthma. Have a history of severe hypertension, ventricular tachycardia or other cardiac disease. Have insulin dependent diabetes mellitus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method