Table 3.
Effect of valproic acid on the steady-state pharmacokinetics of lersivirine (study 2)
| Lersivirine (500 mg once daily) + valproic acid (1000 mg once daily) (n = 14) | Lersivirine (500 mg once daily) + placebo (n = 14) | |||||
|---|---|---|---|---|---|---|
| Parameter (units) | Geometric mean (%CV) | Adjusted geometric mean (A) | Geometric mean (%CV) | Adjusted geometric mean (B) | Ratio of adjusted geometric means (A : B) | 90% CI |
| AUC(0,24 h) (ng ml−1 h) | 9383 (16) | 9383 | 7498 (18) | 7498 | 1.25 | (1.16, 1.35) |
| Cmax (ng ml−1) | 1327 (18) | 1327 | 1295 (18) | 1295 | 1.03 | (0.91, 1.16) |
| Cmin, (ng ml−1) | 62 (37) | 62 | 38 (38) | 38 | 1.63 | (1.49, 1.79) |
| Median (range) | Median (range) | |||||
| tmax (h) | 3.0 (1–6) | 3.0 (2–4) | – | – | ||
AUC(0,24 h), area under the curve over the dosing interval; CI, confidence interval; Cmax, maximum plasma concentration; Cmin, minimum plasma concentration; CV, coefficient of variation; tmax, time for Cmax.