The current requirement of the Mexican Authorities to demonstrate the interchangeability of ranitidine formulations is to establish that the dissolution profile of the drug shows similarity. In order to establish if this requirement is adequate, the bioavailability of two formulations that did not m
Comparative bioavailability study of two tablet formulations of cimetidine
โ Scribed by R. R. Berardi; I. A. Cohen; M. L. Hyneck; G. F. Lockwood; U. A. Shukla; E. Sakmar; J. J. Wells; Dr. J. G. Wagner
- Publisher
- John Wiley and Sons
- Year
- 1984
- Tongue
- English
- Weight
- 378 KB
- Volume
- 5
- Category
- Article
- ISSN
- 0142-2782
No coin nor oath required. For personal study only.
โฆ Synopsis
A two-way crossover bioavailability study of two commercial cimetidine formulations was performed on 24 healthy male volunteers. Drug was administered after an overnight fast and plasma samples were withdrawn periodically for 12 h. Urine was collected throughout the study period. Results indicated that the two formulations were bioequivalent since no statistically significant dinerence in means was detected for any of the parameters studied. Extensive interpatient variation in cimetidine blood concentration was observed during both treatments.
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