metformin steady state study [Regulatives / Guidelines]

posted by jagankm  – 2011-06-01 13:19 (4685 d 02:23 ago) – Posting: # 7046
Views: 10,602

Dear sir,
We are planing to conduct the Steady State BE study of Metformin SR 500 mg tablets in healthy, adult, human volunteers. Just we want to know whether we need to conduct steady state or not, as per SPC and Literature there is No Accumulation is observed after repeated administration of up to 2000 mg of Metformin as prolonged release Tablets. As per Modified released guidelines we need to conduct Fast, Fed and Steady state, Please suggest in this regard.
Your kind help will be highly appreciable.

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