Comparative assessment of the absorption of a generic formulation of ibuprofen sustained release tablet against the innovator ibuprofen sustained release tablet conducted under fasting conditions in healthy male and female volunteers
- Conditions
- Bioequivalence study conducted in healthy volunteers comparing two formulations of Ibuprofen with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, ibuprofen belongs to a class of medicines called an analgesic and anti-inflammatory. It is used for the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and other non-rheumatoid arthropathiesBioequivalence study conducted in healthy volunteers comparing two formulations of Ibuprofen with no health condition or problem studied.Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, ibuprofen belongs to a class of medicines called an analgesic and anti-inflammatory. It is used for the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and other non-rheumatoid arthropathiesOther - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12614001097639
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Healthy male and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 18 and 33 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
Who have received an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study
Sensitivity to ibuprofen or any other similar class of medicines, or the excipients of ibuprofen
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or are breastfeeding
Who are planning to start a family within 60 days of receiving the final dose.
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 60 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 To compare the bioavailability of ibuprofen (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for ibuprofen using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. [0, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14, 15, 16, 20, 24, 26, 28, 30, 32 and 36 hours ]
- Secondary Outcome Measures
Name Time Method Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points. [0, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14, 15, 16, 20, 24, 26, 28, 30, 32 and 36 hours ]