Comparative assessment of the absorption of a generic formulation of buprenorphine transdermal patch against the innovator buprenorphine transdermal patch conducted under fasting conditions and at steady state with the inclusion of a naltrexone block in healthy male and female volunteers
- Conditions
- Buprenorphine is a partial opioid agonist indicated for the management of moderate to severe pain.Anaesthesiology - Pain management
- Registration Number
- ACTRN12616000600448
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
Healthy male and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 30 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 buprenorphine or any other similar class of medicines, or the excipients of buprenorphine
Sensitivity to naltrexone or any other similar class of medicines, or the excipients of naltrexone
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
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 buprenorphine (as summarised by AUC0-t(ss), Cmax(ss) and Cmin(ss)). All plasma samples will be assayed for buprenorphine using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[On day 1 in each study period at pre dose and at 12, 24, 72 and 120 hours post dose application.<br><br>On day 8 in each study period at pre dose and at 48 and 96 hours post dose application.<br><br>On day 15 in each study period the sampling intervals will be at 0, 6, 10, 12, 18, 24 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post dosing.<br>]
- Secondary Outcome Measures
Name Time Method All plasma samples will be assayed for buprenorphine to determine 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.[On day 1 in each study period at pre dose and at 12, 24, 72 and 120 hours post dose application.<br><br>On day 8 in each study period at pre dose and at 48 and 96 hours post dose application.<br><br>On day 15 in each study period the sampling intervals will be at 0, 6, 10, 12, 18, 24 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post dosing.]