The Effect of Telaprevir on the Pharmacokinetics of Buprenorphine in Volunteers on Stable Buprenorphine/Naloxone Maintenance Therapy.

Authors: Luo X, Trevejo J, van Heeswijk RP, Smith F, Garg V
Abstract
This was an open-label, single-sequence trial in HCV-negative volunteers on stable, individualized, buprenorphine maintenance therapy. Telaprevir 750mg every 8 hours was co-administered with buprenorphine/naloxone (4:1 ratio as sublingual tablets) for 7 days with food. Pharmacokinetic profiles of buprenorphine, norbuprenorphine and naloxone were measured over the 24-hour dosing interval on Day -1 (buprenorphine/naloxone alone, reference) and Day 7 of telaprevir co-administration (test). Geometric least squares mean ratios and associated 90% confidence intervals of treatment ratios (test/reference) were calculated using log-transformed pharmacokinetic parameters. Opioid withdrawal symptoms were evaluated throughout…