Table 3.
Effect of steady-state buprenorphine/naloxone on steady-state ritonavir (TPV/r 500/200 mg bid)
| Treatment1 | Mean | SD | Median | Geometric Mean | |
|---|---|---|---|---|---|
| Historical (fasted) | 3.0 | 1.1 | 3.0 | 2.7 | |
| Tmax (h) | Historical (fed) | 3.3 | 2.0 | 4.0 | 2.7 |
| BUP+TPV/r | 2.18 | 1.05 | 1.83 | 1.95 | |
| Historical (fasted) | 2.08 | 1.19 | 1.89 | 1.67 | |
| Cmax (µg/mL) | Historical (fed) | 1.66 | 1.09 | 1.34 | 1.32 |
| BUP+TPV/r | 0.97 | 0.51 | 0.83 | 0.81 | |
| Historical (fasted) | 11.1 | 1.8 | 12.0 | 10.9 | |
| Tmax (h) | Historical (fed) | 11.2 | 1.8 | 12.0 | 11.0 |
| BUP+TPV/r | 11.31 | 1.98 | 11.99 | 11.09 | |
| Historical (fasted) | 0.071 | 0.047 | 0.064 | 0.060 | |
| Clast (µg/mL) | Historical (fed) | 0.095 | 0.087 | 0.061 | 0.073 |
| BUP+TPV/r | 0.160 | 0.241 | 0.068 | 0.084 | |
| Historical (fasted) | 7.7 | 4.5 | 7.4 | 6.1 | |
| AUC0–12h(h·g/mL) | Historical (fed) | 7.3 | 7.3 | 6.1 | 5.9 |
| BUP+TPV/r | 5.10 | 2.92 | 4.72 | 3.88 |
1
Note: Historical results represent the steady-state ritonavir non-compartmental pharmacokinetics for 32 HIV-negative male and female volunteers receiving TPV/r 500/200 mg bid without and with food (BI Study 1182.100); BUP+TPV/r = buprenorphine/naloxone + TPV/r.