Comparative assessment of the absorption of a generic formulation of paracetamol / ibuprofen / doxylamine tablet against the innovator paracetamol / codeine phosphate hemihydrate / doxylamine succinate tablets and paracetamol / ibuprofen tablet conducted under fasting conditions in healthy male and female volunteers
- Conditions
- PainFeverInflammationAllergyInflammatory and Immune System - Other inflammatory or immune system disordersAnaesthesiology - Pain management
- Registration Number
- ACTRN12619001017112
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Healthy males and females
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 32 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to any of the medicines or ingredients
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood in the 30 days preceding the study.
Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This is a composite primary outcome to compare the bioavailability of paracetamol, ibuprofen and doxylamine (as summarised by Cmax and AUC) for all formulations. All plasma samples will be assayed for paracetamol, ibuprofen and doxylamine using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. Codeine phosphate will not be analysed in this study.[Prior to dosing and at 10 min, 20 min, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 16, 20, 24, 36 and 48 hours post dosing.]
- Secondary Outcome Measures
Name Time Method This is a composite secondary outcome measuring Time to maximum peak concentration (Tmax) for paracetamol, ibuprofen and doxylamine combined in one assay. Tmax will be the time where the maximum concentration occurred in the sample points. [Prior to dosing and at 10 min, 20 min, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 16, 20, 24, 36 and 48 hours post dosing.]