A study of two different formulations of buprenorphine in healthy volunteers.

INTERVENTION: Participants will complete two inpatient sessions, with admission the afternoon before dosing, followed by 48 hours of observation after dosing. Study staff will administer to participants a single dose of intravenous buprenorphine 300mcg during one inpatient session and a single dose of sublingual (under‐the‐tongue) buprenoprhine wafer 800 mcg during another session. Study staff will observe the oral cavity to ensure sublingual buprenorphine wafer is dissolved. To block the opioid effects of buprenorphine, 50 mg oral naltrexone will be administered 12 hours and 1 hour pre‐dose and 12 hours post‐dose. The two inpatient sessions will be separated by a minimum of 7 days. No food will be allowed for 10 hours prior to and four hours following dosing. CONDITION: Addiction Pain PRIMARY OUTCOME: To determine the absolute bioavailability of BnoX Trademark sublingual buprenorphine wafer versus intravenous buprenorphine. Standard non‐compartmental analysis methods will be used to obtain PK variables for buprenorphine and norbuprenorphine for both routes of administration. The bioavailability after sublingual dosing will be estimated by the ratio of dose adjusted area under the plasma concentration‐time curve following intravenous and sublingual dosing. SECONDARY OUTCOME: To determine safety and tolerability of a single dose of BnoX (buprenorphine wafer) administered via sublingual route. The most common side effects of buprenoprhine are sedation, drowsiness and dizziness. Participants will be administered Naltrexone to block opioid effects. Safety and tolerability will be monitored by collection of electrocardiograms, vital signs, oxygen saturation, and adverse event monitoring. INCLUSION CRITERIA: 1. Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Principal Investigator. 2. Have suitable venous access for blood sampling. 3. Female participants must not be pregnant or lactating and must be using a reliable form of birth control. 4. BMI within the range of 19‐30 kg/m2 (inclusive). 5. Deemed able to read and understand English in order to communicate with research staff and complete protocol required questionnaires and forms.