Bioequivalence and Bioavailability Forum • metformin steady state study

metformin steady state study [Regulatives / Guidelines]

posted by jagankm – 2011-06-01 13:19 (5086 d 02:35 ago) – Posting: # 7046
Views: 11,680

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.

Complete thread:

metformin steady state studyjagankm 2011-06-01 11:19 [Regulatives / Guidelines]
- metformin steady state study Ohlbe 2011-06-01 11:31
- metformin steady state study drgunasakaran1 2011-06-02 04:24
  - metformin steady state study Ohlbe 2011-06-02 08:56
  - metformin steady state study jagankm 2011-06-02 10:35
    - Steady state (no accumulation) Helmut 2011-06-03 14:58
      - Steady state (no accumulation) Ohlbe 2011-06-06 10:46
        
        Steady state (no accumulation) Helmut 2011-06-06 13:05
        
        Steady state (no accumulation) Ohlbe 2011-06-06 13:54
        
        Science ↔ Guidelines Helmut 2011-06-06 14:06
        
        Science ↔ Guidelines ElMaestro 2011-06-06 22:35
        
        Science ↔ Guidelines Helmut 2011-06-06 23:25
    - metformin steady state study kvgreddy06 2014-07-23 18:32