Comparative assessment of the absorption of a generic formulation of 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet against the innovator 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet administered 12 hours apart conducted under fasting conditions and at steady state in healthy volunteers.
- Conditions
- 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone belongs to a class of medicines called opioid analgesics and is prescribed for the relief of severe pain.Anaesthesiology - Pain management
- Registration Number
- ACTRN12620000812998
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
Healthy males and non-pregnant females
Aged between 18 and 55 years
Non-smoker
BMI greater than or equal to 18.5 and less than 32 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Drug free as determined by urine drug testing
Able to comply with the study restrictions
Able to provide written informed consent
Clinically significant medical conditions
History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
History of alcohol or drug abuse or dependency
Participation in a drug study within 30 days of the start of the study
Sensitivitie to the study drug or excipients
Individuals 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(ss), AUC(ss), Ctau(ss) and DF(ss)) of the test formulation relative to that of the reference formulation. All plasma samples will be assayed for 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.[Pre-dose before each dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10 and 12 hours post dosing on day 3 and 17]
- Secondary Outcome Measures
Name Time Method