TABLE 1.

RAL pharmacokinetic parametersa

ParameterValue for the parameter
RAL aloneRAL with antacidGMRP value
Geometric mean AUC0-12 (ng·h/ml [90% CI])3,042 (2,152-4,298)3,296 (2,928-3,707)1.08 (0.68-1.73)0.762
Geometric mean AUC0-∞ (ng·h/ml [90% CI])3,544 (2,298-5,464)3,415 (2,922-3,996)0.96 (0.62-1.5)0.884
Geometric mean Cmax (ng/ml [90% CI])945 (643-1,386)1,445 (1,295-1,626)1.53 (0.9-2.6)0.175
Geometric mean C12 (ng/ml [90% CI])37 (31-44)13 (11-15)0.33 (0.26-0.42)<0.0001
Median Tmax (h [range])3 (1-6)1 (0.5-3)−1.75 (−4.0-0.5)b0.004
  • a CI, confidence interval; GMR, geometric mean ratio of RAL with antacid/RAL alone; AUC0-12, area under the concentration-time curve from 0 to 12 h after the observed dose; AUC0-∞, AUC from 0 to infinity; C12, concentration at 12 h after the observed dose; Tmax, time to maximum concentration.

  • b Not a geometric mean ratio; the median(range) difference between the value for RAL with antacid and RAL alone.