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[维拉帕米两种缓释制剂的生物利用度]

[Bioavailability of two slow-release formulations of verapamil].

作者信息

Keller-Stanislawski B, Rietbrock N

机构信息

Abtielung für Klinische Pharmakologie, Johann Wolfgang Goethe-Universität, Frankfurt am Main.

出版信息

Arzneimittelforschung. 1990 Oct;40(10):1086-8.

PMID:2291745
Abstract

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).

摘要

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。

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