Comparative assessment of the absorption of a generic formulation of buprenorphine transdermal patch against the innovator buprenorphine transdermal patch conducted under fasting conditions with the inclusion of a naltrexone block in healthy male and female volunteers

INTERVENTION: Single dose, crossover study design whereby each participant receives the test formulation of buprenorphine (1 x 20 mcg/hr) on one occasion and the innovator formulation of buprenorphine (1 x 20 mcg/hr) on one occasion with the inclusion of a naltrexone block given prior to patch application, at application and every 12 hours up until 168 hours post dosing. Each naltrexone dose will be 50 mg. Each buprenorphine dosing will be seperated by a two week washout period. The intervention for this trial is the test formulation of buprenorphine . No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose). Participants are required not to eat for 10 hours before receiving each dose and to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 12 hours prior to dosing to ensure compliance and will be monitored and for 24 hours after dosing. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing. Each buprenorphine patch will be applied to the upper arm. Investigators will examine every subject to ensure the patch has been applied correctly. Each dose of naltrexone will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed. CONDITION: Bioequivalence study conducted in healthy volunteers comparing two formulations of buprenorphine transdermal patch 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, buprenorphine is a partial opioid agonist indicated for the management of moderate to severe pain. PRIMARY OUTCOME: To compare the bioavailability of buprenorphine (as summarised by Cmax and AUC). 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. SECONDARY OUTCOME: 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. INCLUSION CRITERIA: 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