[Bioequivalence of generic drugs and substitution: example of depot verapamil].
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.
Rietbrock
N
N
Abteilung für Klinische Pharmakologie des Klinikums der Johann-Wolfgang-Goethe-Universität, Frankfurt am Main.
Fischer
A
A
Menke
G
G
D001794:Blood Pressure; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D004562:Electrocardiography; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D011897:Random Allocation; D013810:Therapeutic Equivalency; D014700:Verapamil / Q000493:pharmacokinetics / Q000494:pharmacology*
D003692:Delayed-Action Preparations; D014700:Verapamil
Bioäquivalenz von Generika und Substitution: Beispiel retardiertes Verapamil.