Table 3.
Main isosorbide and ibuprofen pharmacokinetic parameters (following the administration of ISO and ibuprofen alone or in combination)
| Pharmacokinetic parameter | Isosorbide | Isosorbide + ibuprofen | t-test | Ibuprofen | Ibuprofen + isosorbide | t-test |
|---|---|---|---|---|---|---|
| Cmax^ | 187±50 | 215±51 | 0.1375 | 60.2±12.8 | 59.4±13.5 | 0.7480 |
| Tmax, minutes | 65±33 | 65±38 | 0.9883 | 108±69 | 110±56 | 0.8106 |
| t1/2, minutes | 303±61 | 280±63 | 0.2206 | 172±105 | 177±85 | 0.1479 |
| AUC0–t° | 1,155±201 | 1,270±234 | 0.0197 | 60.2±12.8 | 59.4±13.5 | 0.7480 |
| AUCt–∞° | 304±141 | 280±119 | 0.5550 | 5.9±8.4 | 6.0±6.6 | 0.0829 |
| AUCextrapolated, % | 20.4±7.1 | 18.3±6.9 | 0.3363 | 8.2±8.8 | 8.7±7.2 | 0.4691 |
| AUC0–∞° | 1,458±266 | 1,533±249 | 0.2409 | 66.1±14.7 | 65.4±15.4 | 0.8765 |
Notes:
^
ng/mL for isosorbide and mg/L for ibuprofen;
°
ng*hour/mL for isosorbide and mg*hour/L for ibuprofen. Values are expressed as means ± standard deviation.
Abbreviations: ISO, isosorbide dinitrate; Cmax, maximum observed plasma drug concentration; Tmax, time at which the Cmax was observed; t1/2, estimated terminal phase half-life; AUC0–t, area under the plasma drug concentration time curve from predose to the last measurable dose; AUC0–∞, area under the concentration time curve versus the time curve up to infinity.