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[仿制药的生物等效性与替换:长效维拉帕米示例]

[Bioequivalence of generic drugs and substitution: example of depot verapamil].

作者信息

Rietbrock N, Fischer A, Menke G

机构信息

Abteilung für Klinische Pharmakologie des Klinikums der Johann-Wolfgang-Goethe-Universität, Frankfurt am Main.

出版信息

Z Kardiol. 1987 Oct;76(10):621-5.

PMID:3318196
Abstract

Following oral administration of 240 mg Verapamil-HCl as Isoptin RR, Veramex SR 240 and durasoptin SR 240, plasma concentration time curves of Verapamil and ECG changes were determined in 14 healthy subjects. There was a linear correlation between maximal plasma concentration and prolongation of PQ-intervals of the ECG. No hysteresis was observed when the changes in PQ-interval were plotted against plasma concentration. Comparison of concentration and effect profiles showed that the three formulations were not equivalent and a change in therapy from one to the other cannot be recommended.

摘要

在14名健康受试者中,口服240毫克盐酸维拉帕米(商品名:异搏定RR、维拉美克缓释片240和度拉索平缓释片240)后,测定了维拉帕米的血浆浓度-时间曲线以及心电图变化。最大血浆浓度与心电图PQ间期延长之间存在线性相关性。当将PQ间期变化与血浆浓度作图时,未观察到滞后现象。浓度和效应曲线的比较表明,这三种制剂不等效,不建议在不同制剂之间更换治疗方案。

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1
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Z Kardiol. 1987 Oct;76(10):621-5.
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PK/PD modelling of high-dose diltiazem--absorption-rate dependency of the hysteresis loop.高剂量地尔硫䓬的药代动力学/药效学建模——滞后环的吸收速率依赖性
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7
[Pertinent correction to "Bioequivalence of generics and substitution: example Verapamil retard].[对“仿制药的生物等效性与替代:维拉帕米缓释片示例”的相关修正]
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