Bioequivalence and Bioavailability Forum • EMEA at its best

EMEA at its best [Design Issues]

posted by drmuneesh – 2009-08-25 08:12 (6143 d 22:07 ago) – Posting: # 4104
Views: 7,558
(edited on 2009-08-25 12:15)

Dear drcampos

Thank you so much for the reply. Can you please tell how many healthy subjects were enrolled in this BE study of Rivastigmine 6mg coadministered with ondansetron and how many subjects suffered from adverse events like nausea and vomiting? And if they had vomiting, was it severe? Any SAEs? Any drop-outs or withdrawals due to AE?

If you can please share all this information, this will help me to conduct the study safely and to make all the required arrangements to manage AEs if any.

Best Regards
Dr Muneesh Garg

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 bestdrmuneesh 2009-08-25 06:12
        
        Rivastigmine BE Dr Lalit 2009-08-25 14:41
        
        Rivastigmine BE drmuneesh 2009-08-26 06:29