Food interaction study of a new theophylline (Egifilin) 200 and 400 mg retard tablet in healthy volunteers.
The aim of the present food interaction study was to determine the blood plasma levels of theophylline upon the administration of new Egifilin 200 and 400 mg retard tablets, either on an empty stomach or after meal, and to make comparative pharmacokinetic evaluation in 26 healthy volunteers. For determination of the plasma levels of theophylline an improved isocratic HPLC-UV method was used in the concentration range of 0.1-18 micrograms/ml. The mean pharmacokinetic curves obtained with 200 and 400 mg tablets before and after meal were in good agreement also on the basis of statistical evaluation, although, as usual with theophylline, the evaluation of the individual pharmacokinetic curves indicated great variations. The pharmacokinetic parameters (AUCzero-t, AUCzero-infinity, HVD, MRT, Cmax, tmax) calculated for Egifilin 200 and 400 mg retard tablets were analyzed by ANOVA, ANOVAlog, Wilcoxon, and Schuirmann statistical tests as well as by the confidence interval calculation. As it was found, under the circumstances of the present food interaction study, food consumption did not have a biologically significant effect on the pharmacokinetic parameters of either the 200 or the 400 mg Egifilin retard preparations.
Urmös
I
I
Department of Pharmacokinetics, EGIS Pharmaceuticals Ltd., Budapest, Hungary.
Grézal
G
G
Balogh Nemes
K
K
Szállási
T
T
Drabant
S
S
Csörgo
M
M
Klebovich
I
I
D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D018565:Food-Drug Interactions / Q000502:physiology*; D006207:Half-Life; D006801:Humans; D013056:Spectrophotometry, Ultraviolet; D013806:Theophylline / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*
D018927:Anti-Asthmatic Agents; D003692:Delayed-Action Preparations; D013806:Theophylline