Pharmacokinetics and Bioequivalence study of ranitidine film tablets in healthy male subjects
| Autor: | Michael H. Gschwend, Uygur Tamur, Aydin Erenmemisoglu, Richard Guserle, A. Atilla Hincal, Wolfgang Martin, Ilker Kanzik |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Quality Control Adolescent Cmax Bioequivalence Pharmacology Ranitidine Dosage form Pharmacokinetics Drug Discovery medicine Humans Chromatography High Pressure Liquid Cross-Over Studies Chromatography business.industry Crossover study Bioavailability Histamine H2 Antagonists Therapeutic Equivalency Area Under Curve Ranitidine Hydrochloride Calibration Spectrophotometry Ultraviolet business Half-Life Tablets medicine.drug |
| Popis: | 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 %. |
| Databáze: | OpenAIRE |
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