Reseach and Development product data

From time to time we will issue information relating to specific research and clinical products. These will be added as and when required.

Galantamine 8mg

Generics [UK] Ltd a subsidiary of Mylan is pleased to announce that after developing a generic version of sustained release formulation of the galantamine 8mg product we have now shown it bioequivalent to the brand product Reminyl(r) XL under fed, fasted and multiple dose conditions. The data from the bioequivalence studies is summarised below and it can be seen that all the common pharmacokinetic paramaters required to show equivalence pass current guideline criteria. Mean ratios of parameters are close to unity and confidence intervals of key parameters meet the 80-125% targets. The studies showed the products to have similar adverse event profiles.

Galantamine 8mg Results Summary

(Page Created: 14-05-2008)

(Last Updated: 12-09-2008)