Bioequivalence and Bioavailability Forum • Rivastigmine BE

Rivastigmine BE [Design Issues]

posted by Dr Lalit – 2009-08-25 16:41 (6152 d 00:13 ago) – Posting: # 4111
Views: 7,670

Dear Dr Munish,

I have conducted a Pilot BE study on Rivastigmin 6 mg a few years back, hence let me share my experience on this. To tell you in short it's bad... very bad. The drug at that strength causes a lot of AE (Severe Retching with Hot Flushes and dizziness along with palpitation with Tachycardia) in many a subjects thus leading to a series of deviation in the study, since the sample time points are so close. It was quite a problem to tackle all the AE in such a short span of time as all most 30 to 40 % of the subjects were involved (not to forget Oesophageal Rupture that could lead to haemoptysis being at the back of my mind while attending these subjects).
It was interesting to note that the other subjects did not have any AE and were quite comfortable at that dose.

Regards
Dr Lalit Anande

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 BEDr Lalit 2009-08-25 14:41
        
        Rivastigmine BE drmuneesh 2009-08-26 06:29