摘要
12名健康志愿者随机自身交叉口服单剂量500mg国产克拉霉素胶囊或进口片剂进行生物利用度研究,用微生物杯碟法测定血清中克拉霉素浓度。结果表明克拉霉素胶囊和片剂两种制剂的体内药时数据符合二室模型,Cmax分别为2.44和2.78μg/ml;tp为2.29和2.07h;为6.81和7.39h;AUC为23.68和24.05mg·h·L-1。克拉霉素胶囊相对生物利用度为99.86±19.28%,表明国产克拉霉素胶囊与进口片剂具有生物等效性。
he
bioavailability of clarithromycin capsule was studied in 12 normal male volunteers. A single
oral dose of 500mg clarithromycin capsule or tablet was given according to a crossover design.
Serum concentrations of clarithromycin were measured by bioassay. The concentration - time
curves of both capsule and tablet fitted to a two - compartment open model. Peak serum levels
of capsule and tablet reached 2.44 and 2.78μg/ml, at 2.29 and 2. 07h. respectively. The were
6.80 and 7.39h. The AUC were 23.68 and 24.05mg . h . L . ,respectively. The relative
bioavailability of capsule to tablet was 99.8±19.28%, and it demonstrated that both formation
had bioequivalence.
出处
《重庆医科大学学报》
CAS
CSCD
1999年第2期161-163,共3页
Journal of Chongqing Medical University