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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 Summary
results
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