Joseph T, Gowrishankar R
Department of Pharmacology, St John's Medical College, Bangalore.
Indian J Physiol Pharmacol. 1996 Jul;40(3):253-6.
Bioavailability studies with single oral doses of omeprazole 20 mg (enteric coated formulation) and felodipine 10 mg (extended release formulation) were performed in Indian volunteers to confirm that adequate plasma concentrations are obtained in Indian subjects. Plasma samples were analysed by chromatographic methods. The AUCs of omeprazole were about 3 fold higher and those of felodipine 2 fold higher than AUCs reported in Western subjects. This has no toxicological implications with respect to omeprazole, but whether lower dose of omeprazole may be sufficient in Indian patients with acid related diseases would require acid inhibition studies. In the case of felodipine the higher AUCs in Indian subjects suggest a need for a lower strength formulation (2.5 mg) to fine-titrate the dosage to obtain optimal antihypertensive effects with minimal adverse effects.
在印度志愿者中进行了单剂量口服20毫克奥美拉唑（肠溶包衣制剂）和10毫克非洛地平（缓释制剂）的生物利用度研究，以确认印度受试者能够获得足够的血浆浓度。通过色谱法分析血浆样本。奥美拉唑的AUC比西方受试者报告的AUC高约3倍，非洛地平的AUC比西方受试者报告的AUC高2倍。这对奥美拉唑没有毒理学影响，但对于患有酸相关疾病的印度患者，较低剂量的奥美拉唑是否足够需要进行胃酸抑制研究。就非洛地平而言，印度受试者中较高的AUC表明需要较低强度的制剂（2.5毫克）来精确调整剂量，以获得最佳降压效果并使不良反应最小化。
