Table 3

Sulindac sulfone pharmacokinetic parameters after the first dose

Parameter values determined using WinNonlin software and noncompartmental analysis.

Tmax hCmax mg/lT1/2 hAUC mg × h/LVβ/Fb literCLs/Fb l/hMRT hVss/Fb liter
200-mg dose
Mean2.254.916.2927.9676.848.228.1769.26
SD0.6122.161.4210.241.83.671.6640.4
300-mg dose
Mean1.9311.086.8149.2172.008.187.9158.80
SD0.54.182.1730.135.14.53.036.8
400-mg dosea
Mean2.509.854.8848.765.510.16.6560.1
SD2.002.661.4027.421.24.583.2124.8
  • a Values from one subject with outlying results were omitted from the mean and SD calculations at the 400-mg bid dose level.

  • b F is the fraction of the oral dose that reaches the systemic circulation. Because the dose was administered orally, the value of F was unknown and potentially <1.00. This uncertainty in F was transmitted to the clearance and volume of distribution values, i.e., if F <1, then the clearance and volume of distribution values are larger than the true values. For this reason, these parameters were shown divided by F; F was omitted when the symbols were used in the text.