Abstract
The authors performed a detailed comparative clinical and pharmacokinetic study with two 800 mg acyclovir containing tablets, namely the Telviran® (EGIS Pharmaceuticals Ltd.) and the Zovirax® (Wellcome Foundation Ltd.). The determination of the detailed pharmacokinetic parameters and the relative bioavailability was carried out on 24 healthy male volunteers in a two way, open, randomised, cross-over design study after single dose administration. The plasma concentration of acyclovir was determined by a newly developed and validated highly sensitive (LLOQ = 10 ng/ml) HPLC-UV bioanalytical method, after sample preparation with RP-18 solid phase extraction method (SPE). The individual pharmacokinetic parameters calculated from the time-plasma concentration curve (t(max), C(max), AUC(0-∞), AUC0-16, AUC(0-t), AUC(0-z), AUC(Rest), t(β)( 1/2 ), MRT, C(max)/AUC(0-∞)) were compared with statistical methods (ANOVA, ANOVA(log), Confidence interval, Schuirmann, Wilcoxon tests). On the basis of the results of the statistical evaluation and the clinical study, there was no significant difference found between the two acyclovir containing preparations. The comparative pharmacokinetic study demonstrated, that the relative bioavailability of the 800 mg Telviran® and Zovirax® tablets are equivalent and the two products are bioequivalent.
| Original language | Hungarian |
|---|---|
| Pages (from-to) | 36-45 |
| Number of pages | 10 |
| Journal | Acta Pharmaceutica Hungarica |
| Volume | 69 |
| Issue number | 1 |
| Publication status | Published - Jan 1999 |
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ASJC Scopus subject areas
- Pharmaceutical Science
Cite this
Telviran® es Zovirax® 800 mg acyclovir hatoanyagtartalmu tablettak osszehasonlito farmakokinetikaja egeszseges onkenteseken. / Katalin, Baloghné Nemes; Gyula, Grézal; Borbála, Dalmadiné Kiss; Judit, Tömlo; Valentina, Patai; Lajos, Nagy; Mózsik, G.; Margit, Csörgo; Imre, Szentpéteri; Klebovich, I.
In: Acta Pharmaceutica Hungarica, Vol. 69, No. 1, 01.1999, p. 36-45.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Telviran® es Zovirax® 800 mg acyclovir hatoanyagtartalmu tablettak osszehasonlito farmakokinetikaja egeszseges onkenteseken
AU - Katalin, Baloghné Nemes
AU - Gyula, Grézal
AU - Borbála, Dalmadiné Kiss
AU - Judit, Tömlo
AU - Valentina, Patai
AU - Lajos, Nagy
AU - Mózsik, G.
AU - Margit, Csörgo
AU - Imre, Szentpéteri
AU - Klebovich, I.
PY - 1999/1
Y1 - 1999/1
N2 - The authors performed a detailed comparative clinical and pharmacokinetic study with two 800 mg acyclovir containing tablets, namely the Telviran® (EGIS Pharmaceuticals Ltd.) and the Zovirax® (Wellcome Foundation Ltd.). The determination of the detailed pharmacokinetic parameters and the relative bioavailability was carried out on 24 healthy male volunteers in a two way, open, randomised, cross-over design study after single dose administration. The plasma concentration of acyclovir was determined by a newly developed and validated highly sensitive (LLOQ = 10 ng/ml) HPLC-UV bioanalytical method, after sample preparation with RP-18 solid phase extraction method (SPE). The individual pharmacokinetic parameters calculated from the time-plasma concentration curve (t(max), C(max), AUC(0-∞), AUC0-16, AUC(0-t), AUC(0-z), AUC(Rest), t(β)( 1/2 ), MRT, C(max)/AUC(0-∞)) were compared with statistical methods (ANOVA, ANOVA(log), Confidence interval, Schuirmann, Wilcoxon tests). On the basis of the results of the statistical evaluation and the clinical study, there was no significant difference found between the two acyclovir containing preparations. The comparative pharmacokinetic study demonstrated, that the relative bioavailability of the 800 mg Telviran® and Zovirax® tablets are equivalent and the two products are bioequivalent.
AB - The authors performed a detailed comparative clinical and pharmacokinetic study with two 800 mg acyclovir containing tablets, namely the Telviran® (EGIS Pharmaceuticals Ltd.) and the Zovirax® (Wellcome Foundation Ltd.). The determination of the detailed pharmacokinetic parameters and the relative bioavailability was carried out on 24 healthy male volunteers in a two way, open, randomised, cross-over design study after single dose administration. The plasma concentration of acyclovir was determined by a newly developed and validated highly sensitive (LLOQ = 10 ng/ml) HPLC-UV bioanalytical method, after sample preparation with RP-18 solid phase extraction method (SPE). The individual pharmacokinetic parameters calculated from the time-plasma concentration curve (t(max), C(max), AUC(0-∞), AUC0-16, AUC(0-t), AUC(0-z), AUC(Rest), t(β)( 1/2 ), MRT, C(max)/AUC(0-∞)) were compared with statistical methods (ANOVA, ANOVA(log), Confidence interval, Schuirmann, Wilcoxon tests). On the basis of the results of the statistical evaluation and the clinical study, there was no significant difference found between the two acyclovir containing preparations. The comparative pharmacokinetic study demonstrated, that the relative bioavailability of the 800 mg Telviran® and Zovirax® tablets are equivalent and the two products are bioequivalent.
UR - http://www.scopus.com/inward/record.url?scp=14444276080&partnerID=8YFLogxK
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M3 - Article
VL - 69
SP - 36
EP - 45
JO - Acta Pharmaceutica Hungarica
JF - Acta Pharmaceutica Hungarica
SN - 0001-6659
IS - 1
ER -