Investigation of bioequivalence of calcitriol capsules and Rocaltrol in healthy volunteers
Author(s): WEN Qing, WANG Benjie, ZHENG Xiuying, CONG Jiang, CUI Zuo, HOU Guihua, GUO Ruichen
Pages: 495-496,499
Year: 2002 Issue: 6
Journal: JOURNAL OF SHANGDONG UNIVERSITY(HEALTH SCIENCES)
Keyword: 骨化三醇胶丸; 生物等效性; 放射免疫测定;
Abstract: 目的:比较试验制剂骨化三醇胶丸与参比制剂市售罗钙全的生物等效性.方法:18名健康志愿者单剂双交叉口服试验制剂或参比制剂4.0μg(0.25 μg×16粒),分别取前臂静脉血4ml,离心,分离血清-20℃保存.采用放免法测定骨化三醇血浓度,评价试验制剂和参比制剂的生物等效性.结果:试验制剂骨化三醇胶丸和参比制剂罗钙全主要药代动力学参数t1/2(β)分别为(8.57+1.49)h和(8.60+1.48)h,Tpeak分别为(4.17+1.25)h和(4.33+1.37)h,Cmax分别为(366.22+82.90)pg/ml和(357.03+76.84)pg/ml,AUC0～48分别为(5019.51±1217.04)pg/ml@h和(4986.50±1112.58)pg/ml@h,AUC0～∞分别为(5729.52±1154.64)pg/ml@h和(5790.30±1085.41)pg/ml@h.试验制剂骨化三醇胶丸相对生物利用度F为99.14%±11.25%.结论:骨化三醇胶丸与罗钙全具有生物等效性.
Pages: 495-496,499
Year: 2002 Issue: 6
Journal: JOURNAL OF SHANGDONG UNIVERSITY(HEALTH SCIENCES)
Keyword: 骨化三醇胶丸; 生物等效性; 放射免疫测定;
Abstract: 目的:比较试验制剂骨化三醇胶丸与参比制剂市售罗钙全的生物等效性.方法:18名健康志愿者单剂双交叉口服试验制剂或参比制剂4.0μg(0.25 μg×16粒),分别取前臂静脉血4ml,离心,分离血清-20℃保存.采用放免法测定骨化三醇血浓度,评价试验制剂和参比制剂的生物等效性.结果:试验制剂骨化三醇胶丸和参比制剂罗钙全主要药代动力学参数t1/2(β)分别为(8.57+1.49)h和(8.60+1.48)h,Tpeak分别为(4.17+1.25)h和(4.33+1.37)h,Cmax分别为(366.22+82.90)pg/ml和(357.03+76.84)pg/ml,AUC0～48分别为(5019.51±1217.04)pg/ml@h和(4986.50±1112.58)pg/ml@h,AUC0～∞分别为(5729.52±1154.64)pg/ml@h和(5790.30±1085.41)pg/ml@h.试验制剂骨化三醇胶丸相对生物利用度F为99.14%±11.25%.结论:骨化三醇胶丸与罗钙全具有生物等效性.
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