Keller-Stanislawski B, Rietbrock N
Abtielung für Klinische Pharmakologie, Johann Wolfgang Goethe-Universität, Frankfurt am Main.
Arzneimittelforschung. 1990 Oct;40(10):1086-8.
The bioavailability of 2 slow release formulations (test (P) and reference (R)) of verapamil was investigated in a study with a randomised cross over design, 20 healthy male subjects were included. The mean peak plasma concentration (36.1 +/- 13.1 ng/ml) of the test preparation was reached after 3.75 +/- 0.8 h. The control preparation (R) produced peak values of 34.4 +/- 8.1 ng/ml after 5.6 +/- 3.1 h. MRT (P) was 17.6 +/- 8.2 h and for (R) was 21.1 +/- 7.5 h after (R). The 95-%-confidence interval of the two preparations differed by more than 20%. The release rate of (P) is slower than that of (R).
在一项采用随机交叉设计的研究中，对维拉帕米的两种缓释制剂（试验制剂（P）和参比制剂（R））的生物利用度进行了研究，纳入了20名健康男性受试者。试验制剂的平均血浆峰浓度（36.1±13.1 ng/ml）在3.75±0.8小时后达到。对照制剂（R）在5.6±3.1小时后产生的峰值为34.4±8.1 ng/ml。试验制剂（P）的平均滞留时间为17.6±8.2小时，参比制剂（R）在给药后的平均滞留时间为21.1±7.5小时。两种制剂的95%置信区间相差超过20%。制剂（P）的释放速率比制剂（R）慢。
