[Bioequivalence and bioavailability after single administration of effervescent ranitidine tablets].
An open two-way cross-over study in 12 healthy male volunteers was performed in order to determine the relative bioavailability of a 150 mg ranitidine (Zantic, CAS 66357-35-5) effervescent tablet sweetened with saccharine in comparison to the 150 mg standard ranitidine dispersible tablet (Trinkette). On two occasions separated by a wash-out period of 1 week volunteers received a single oral dose of both formulations. On each administration day blood samples were collected at predetermined time points in order to investigate the pharmacokinetic parameters. Single oral doses of ranitidine were very well tolerated by healthy male volunteers. The non-parametric 95% confidence intervals for AUC and Cmax were 87 to 116% and 84 to 107%, respectively. The relative bioavailability of the ranitidine effervescent tablet was 99% compared to the dispersible tablet. The mean of the Cmax ratio was 95%. The ranitidine effervescent tablet could thus be claimed to be bioequivalent to the dispersible tablet.
Hartmann
B
B
Medizin und Forschung, Glaxo GmbH, Bad Oldesloe.
Schmieder
G
G
Tetzloff
W
W
Töberich
H
H
D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D008297:Male; D011899:Ranitidine / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013607:Tablets
D013607:Tablets; D011899:Ranitidine
Bioäquivalenz und Bioverfügbarkeit nach Einmalgabe von löslichen Ranitidin-Tabletten.