Bioequivalence and Bioavailability Forum • Rivastigmine 6 mg: patients?

Rivastigmine 6 mg: patients? [Design Issues]

posted by Helmut – Vienna, Austria, 2009-08-22 01:17 (6151 d 13:37 ago) – Posting: # 4091
Views: 8,043

Dear Muneesh,

you are sugesting some heavy stuff.

❝ […] literature available on the internet, in which bioequivalence study was done with Rivastigmine Tartrate 6 mg strength with dimenhydinate 75 mg inj I/M given 10 min before dosing and 3 hrs after dosing to prevent nausea and vomiting. But even after concomitant medication there were cases with nausea and vomiting.

Horrible. Can you give us this link?

❝ Please let me know what can be best done to prevent nausea and vomiting.

No idea. See this thread for a controversial discussion. FDA (draft 04/2009) recommends for the 6 mg strength a study in patients in steady state. FDA also considers the option of a biowaiver (good luck).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

BE study of Rivastigmine 6 mg in healthy volunteers drmuneesh 2009-08-21 10:59
- Rivastigmine 6 mg: patients?Helmut 2009-08-21 23:17
  - Rivastigmine 6 mg: patients? drmuneesh 2009-08-22 06:51
    - Rivastigmine 6 mg (EU centralised procedure) Helmut 2009-08-22 13:56
    - Rivastigmine 6 mg: patients? ElMaestro 2009-08-22 17:47
      - EMEA at its best Helmut 2009-08-22 18:37
        
        EMEA at its best ElMaestro 2009-08-22 19:17
        
        EMEA at its best drmuneesh 2009-08-24 13:59
        
        EMEA at its best drcampos 2009-08-24 19:26
        
        EMEA at its best drmuneesh 2009-08-25 06:12
        
        Rivastigmine BE Dr Lalit 2009-08-25 14:41
        
        Rivastigmine BE drmuneesh 2009-08-26 06:29