This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
This is an open-label study intended to evaluate the relative bioavailability of 4 Probuphine implants versus 16mg QD sublingual buprenorphine, as determined by plasma BPN AUC(0-24), during 24 hours at steady state. This study will also provide open-label safety and tolerability data in patients treated with Probuphine.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants)
16 mg/day, QD
Segal Institute For Clinical Research
Fort Lauderdale, Florida, United States
Plasma BPN AUC(0-24)during 24 hours at steady state.
Time frame: Day -1, Day -2 and Week 4
Plasma BPN and NorBPN Cmax
Time frame: week 4
Time to maximum plasma BPN and NorBPN concentration (tmax)
Time frame: Day -2, Day -1 and Day 1
Plasma BPN and NorBPN AUC(0-24) during 24 hours at steady state
Time frame: week 4
Change in plasma BPN concentration
Time frame: 24 weeks
Number of subjects with adverse events as a measure of safety and tolerability
Adverse events that occurred after the signing of informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and Serious AEs until resolution or stabilization, were followed.
Time frame: approx. 11 weeks (due to study termination)
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