Smith T C, Kinkel A
Clin Pharmacol Ther. 1976 Dec;20(6):738-42. doi: 10.1002/cpt1976206738.
Crossover studies were conducted to compare plasma levels of phenytoin and urinary throughput of the major metabolite, 5-(p-hydroxyphenyl)-5-phenylhydantoin (HPPH), after ingestion of single 250-mg oral doses as tablets or as capsules. Plasma levels of phenytoin did not differ significantly for the 2 formulations except at 8 and 12 hr after ingestion of drug, when the mean values for the tablets were higher than for the capsules. The normalized area under the curve, however, did not differ significantly for either preparation, indicating that equivalent amounts of each preparation were absorbed. Urinary throughput of HPPH did not differ significantly between the 2 preparations. The results suggest that the 2 preparations provide equivalent therapeutic effects.
进行了交叉研究,以比较单次口服250毫克苯妥英钠片或胶囊后,苯妥英钠的血浆水平和主要代谢产物5-(对羟基苯基)-5-苯基乙内酰脲(HPPH)的尿排泄量。除服药后8小时和12小时外,两种剂型的苯妥英钠血浆水平无显著差异,此时片剂的平均值高于胶囊。然而,两种制剂的曲线下归一化面积无显著差异,表明每种制剂吸收的量相等。两种制剂之间HPPH的尿排泄量无显著差异。结果表明,两种制剂具有同等的治疗效果。