Bioequivalence and Bioavailability Forum • BE study of Rivastigmine 6 mg in healthy volunteers

BE study of Rivastigmine 6 mg in healthy volunteers [Design Issues]

posted by drmuneesh – 2009-08-21 12:59 (6150 d 23:58 ago) – Posting: # 4086
Views: 9,052

Dear All

I am planning to conduct a bioequivalence study of Rivastigmine Tartrate on 6 mg strength in healthy volunteers.

As higher doses may not be tolerated in healthy subjects as nausea, vomiting, and dizziness are the most commonly reported adverse reactions. Some times severe vomiting is associated with oesophageal rupture.

According to some 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.

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

Best Regards
Dr Muneesh Garg

Edit: Category changed. [Helmut]

Complete thread:

BE study of Rivastigmine 6 mg in healthy volunteersdrmuneesh 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