Table 4.
Pharmacokinetic Parameter | Buprenorphine-Naloxone Group | Control Group | P Value |
Darunavir (n = 11 in each group) | |||
AUC0–24, h*μg/mL | 79.4 (18.0) | 71.0 (19.7) | .31 |
CL/F, L/h | 10.54 (2.32) | 11.94 (2.74) | .21 |
Cmax, μg/mL | 7.2 (1.2) | 6.9 (1.4) | .54 |
Tmax, hours, median (range) | 4.0 (1.0–6.0) | 2.0 (1.5–6.0) | .85 |
T1/2, hours | 18.7 (8.1) | 15.9 (9.8) | .28 |
Amprenavir (active metabolite of fosamprenavir; n = 10 in each group) | |||
AUC0–24, h*μg/mL | 67.4 (24.3) | 71.2 (36.3) | .79 |
CL/F, L/h | 24.5 (12.6) | 29.2 (24.0) | .59 |
Cmax, μg/mL | 7.2 (2.7) | 7.5 (4.7) | .86 |
Tmax, hours, median (range) | 2.5 (1.0–4.0) | 3.5 (1.0–4.0) | .34 |
T1/2, hours | 23.1 (15.0) | 17.3 (9.7) | .32 |
Abbreviations: AUC, area under the concentration time curve; C24, trough plasma concentration; Cmax, maximum plasma concentration; CL/F, bioavailability-adjusted clearance; Tmax, time of Cmax; T1/2, elimination half-life.
Data are mean (standard error) values, unless otherwise indicated. All parameter values are adjusted to a standard dose of 16 mg of buprenorphine daily.