TABLE 3.

Ratio estimate of log-transformed pharmacokinetic parameters

Treatment comparisonCmax (ng/ml)AUC (ng·h/ml)a
Part 1: effect of gastric pH (n = 12)
    Posaconazole 400 mg SDb + acidic carbonated beverage vs posaconazole alone192 (151-244)c170 (143-2,030)
    Posaconazole 400 mg SD + PPI vs posaconazole alone54 (43-69)68 (57-81)
    Posaconazole 400 mg SD + PPI + acidic carbonated beverage vs posaconazole alone67 (53-86)79 (66-94)
Part 2: effect of dosing regimen (BID/QID) and prandial state (n = 12)
    Posaconazole 400 mg BID + nutritional supplement vs posaconazole 400 mg alone165 (129-211)166 (130-213)
    Posaconazole 200 mg QID alone vs posaconazole 400 mg alone236 (184-302)261 (204-335)
    Posaconazole 200 mg QID + nutritional supplement vs posaconazole 400 mg alone237 (186-304)257 (200-330)
Part 3: effect of food and meal timing (n = 12)
    Posaconazole 400 mg SD before meal vs fasted196 (148-259)211 (160-278)
    Posaconazole 400 mg SD during meal vs fasted439 (332-580)482 (366-635)
    Posaconazole 400 mg SD after meal vs fasted433 (328-573)487 (370-642)
Part 4: Effect of gastric motility
    Posaconazole 400 mg SD + nutritional supplement + metoclopramide vs posaconazole 400 mg + nutritional supplement79 (72-87)81 (72-91)
    Posaconazole 400 mg SD + nutritional supplement + loperamide vs posaconazole 400 mg + nutritional supplement97 (88-107)111 (99-125)
  • a The AUC to the final measurable sampling time for parts 1, 3, and 4 and the dose-normalized AUC during the dosing interval (AUCτ/dose) for part 2.

  • b SD, single dose.

  • c Values in parentheses are 90% confidence intervals.