Comparative assessment of the absorption of a generic formulation of a combination N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension against two innovator formulations administered simultaneously of N-(4-hydroxyphenyl)acetamide oral suspension and (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension conducted under fasting conditions in healthy volunteers.
- Conditions
- -(4-hydroxyphenyl)acetamide is an effective analgesic and antipyretic. It is indicated for the temporary relief of pain, discomfort associated with teething, headache, earache, immunisation, toothache, cold and flu, and it reduces fever.(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid is a nonsteroidal anti-inflammatory drug used for the temporary relief of fever, pain associated with teething, toothache, earache, sore throat, headache, minor ache, sprain, strain, cold and flu.N-(4-hydroxyphenyl)acetamide is an effective analgesic and antipyretic. It is indicated for the temporary relief of pain, discomfort associated with teething, headache, earache, immunisation, toothache, cold and flu, and it reduces fever.Anaesthesiology - Pain managementInflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12621001446853
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 24
Healthy males and 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
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 To evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the test formulation relative to that of the reference formulation. All plasma samples will be assayed for N-(4-hydroxyphenyl)acetamide and (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.[0 (pre-dose) and at 10 min, 20 min, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 14 hours post dosing.]
- 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 (pre-dose) and at 10 min, 20 min, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 14 hours post dosing.]