Comparative assessment of the absorption of a generic formulation of 5 mg oxycodone tablet against the innovator 5 mg oxycodone tablet conducted under fasting conditions in healthy male and female volunteers.
- Conditions
- Bioequivalence study conducted in healthy volunteers comparing two formulations of oxycodone 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, oxycodone belongs to a class of medicines called opioid analgesics and is prescribed for the relief of pain.Bioequivalence study conducted in healthy volunteers comparing two formulations of oxycodone 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, oxycodone belongs to a class of medicines called opioid analgesics and is prescribed for the relief of pain.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12613001286730
- 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 non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 19 and 30
Normal, healthy individuals as determined by medical history, physical examination, ECG, bood 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 excluding prescribed hormonal contraceptives
Who have receievd an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study
History or family history of depression or other mental illness, epilepsy or seizures
Sensitivity to oxycodone, any opioid analgesic medicines, excipients of oxycodone
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Who are lactose intolerant
Females who are breastfeeding or are planning to start a family within 60 days of dosing
Who are planning on having any surgical or dental procedures within 4 weeks of the study completion
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 oxycodone (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for oxycodone using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. [0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.25, 2.5, 3.0, 4.0, 5.0, 7.0, 9.0, 10.0, 12.0, 15.0 and 24 hours]
- Secondary Outcome Measures
Name Time Method Time to maximum peak concentration (Tmax) and the elimination half life (t1/2). Tmax will be the time where the maximum concentration occurred in the sample points. T1/2 = 0.693/Kel where kel is the terminal elimination rate constant. [0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.25, 2.5, 3.0, 4.0, 5.0, 7.0, 9.0, 10.0, 12.0, 15.0 and 24 hours]