Pharmacokinetics and bioequivalence study of ranitidine film tablets in healthy male subjects.
The aim of the present study was to compare the bioavailability of ranitidine (CAS 66357-35-5) from two different ranitidine hydrochloride (CAS 66357-59-3) film tablets (Ranitab 150 mg film tablets as test preparation and 150 mg film tablets of the originator product as reference preparation). The study was conducted according to an open-label, randomised two-period cross-over design with a wash-out phase of 9 days. Blood samples for pharmacokinetic profiling were taken up to 24 h post-dose, and ranitidine plasma concentrations were determined with a validated HPLC method with UV-detection. Maximum plasma concentrations (Cmax) of 461.8 ng/ml (test) and 450.6 ng/ ml (reference) were achieved. Areas under the plasma concentration-time curve (AUC (0-infinity) of 2,488.6 ng . h/ml (test) and 2,528.8 ng . h/ml (reference) were calculated. The median tmax was 2.83 h (test) and 3.04 h (reference). Plasma elimination half-lives (t1/2) of 2.78 h (test) and 2.89 h (reference) were determined. Both primary target parameters AUC(0-infinity) and Cmax were tested parametrically by analysis of variance (ANOVA) and the 90% confidence intervals were between 91.93 %-106.98 % (AUC (0-infinity) and 92.34%-118.85% (Cmax). Bioequivalence between test and reference preparation was demonstrated since for both parameters AUC and Cmax the 90 % confidence intervals of the T/R ratios of logarithmically transformed data were in the generally accepted range of 80 %-125 %.
Pharmakin GmbH, Gesellschaft für Pharmakokinetik, Graf-Arco-Str. 3, 89079 Ulm, Germany. michael.gschwend@pharmakin.de
Michael H
MH
Gschwend
Richard
R
Guserle
Aydin
A
Erenmemişoglu
Wolfgang
W
Martin
Uygur
U
Tamur
Ilker
I
Kanzik
A Atilla
AA
Hincal
D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006207:Half-Life; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D011786:Quality Control; D011899:Ranitidine / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D013810:Therapeutic Equivalency
D006635:Histamine H2 Antagonists; D013607:Tablets; D011899:Ranitidine