[Bioanalytic examination and pharmacokinetics of captopril. Bioequivalence studies of different captopril-containing Tensiomin preparations].
The authors of the present report reviewed the literature of various bioanalytical methods for the pharmacokinetics and metabolism of captopril and present their own results obtained in bioanalytical and pharmacokinetic studies. The authors performed a detailed comparative clinical, pharmacokinetic and bioequivalence study, in Hungary, with 3 different captopril tablets, 50 mg each, namely with Tensiomin (EGIS Pharmaceuticals Ltd.), as test preparation and Capoten (E.R. Squibb & Sons, Inc.) and Lopirin (Squibb Pharma GmbH) as reference preparations. Bioequivalence study of Tensiomin and Capoten preparations both containing 100 mg of captopril was carried out in the United States. Relative bioavailability and comparative pharmacokinetic parameters were determined in 24 and 25 healthy volunteers, respectively, in single-dose, randomised studies of three-way (50 mg) or two-way (100 mg) cross-over design. The individual pharmacokinetic parameters determined for the test and reference preparations with different active principle content were tmax, Cmax, AUCOo-t, AUCo-infinity t beta 1/2, Cmax/AUCo-infinity. Statistical evaluation of the results of bioequivalence studies was made using confidence interval calculation and the Test/Reference ratio (50 and 100 mg), and by Schuirmann's, Hauck-Anderson's, Westlake's, Wilcoxon's methods (50 mg) and power test (100 mg). All the above tests indicated statistical equivalence between the test and reference preparations. The test and reference preparations of different strengths had identical relative bioavailability. Accordingly, the clinical and biological equivalence of 50 mg and 100 mg Tensiomin tablets with 50 mg and 100 mg Capoten tablets and 50 mg Lopirin tablet have been demonstrated in two independent comparative bioequivalence studies.
Klebovich
I
I
EGIS Gyógyszergyár Rt., Farmakokinetikai Kutató Laboratórium, Budapest.
Benköné
M S
MS
D000284:Administration, Oral; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D001682:Biological Availability; D002216:Captopril / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D006801:Humans; D008657:Metabolic Clearance Rate; D011897:Random Allocation; D013607:Tablets
D000806:Angiotensin-Converting Enzyme Inhibitors; D013607:Tablets; D002216:Captopril