TABLE 2.
Plasma pharmacokinetic parameters for raltegravir following single oral dose of 400-mg raltegravir with or without multiple oral doses of 600-mg efavirenz
| Pharmacokinetic parameter | No. of subjects | Geometric mean
|
Value for raltegravir + efavirenz/value for raltegravir
|
||
|---|---|---|---|---|---|
| Raltegravir + efavirenz | Raltegravir | GMR (90% CI) | P value | ||
| C12 h (nM)a | 9 | 62.5 | 79.1 | 0.79 (0.49, 1.28) | 0.388 |
| AUC0-∞ (μM · h)a | 9 | 18.14 | 28.15 | 0.64 (0.52, 0.80) | 0.006 |
| Cmax (μM)a | 9 | 6.45 | 10.13 | 0.64 (0.41, 0.98) | 0.089 |
| Tmax (h) | 9 | 1.5b | 1.5b | −0.1 (−1.0, 2.2)c | 0.984 |
| t1/2 α (h) | 9 | 0.95d | 0.98d | −0.06 (−0.14, 0.16)c | 0.414 |
| t1/2 β (h) | 9 | 9.1d | 10.8d | −0.6 (−4.4, 2.7)c | 0.820 |
a
Geometric mean computed from least-squares estimate from an analysis of variance performed on the natural-log transformed values.
b
Median reported for Tmax.
c
Hodges-Lehman estimate of median treatment difference with corresponding 90% CI for true median treatment difference.
d
Harmonic mean reported for t1/2.