Bioequivalence and Bioavailability Forum

Failed Fed study on Indapamide MR [Study Assessment]

posted by jag009 – NJ, 2013-11-19 20:45 (4596 d 09:57 ago) – Posting: # 11919
Views: 14,640

Hi,

❝ We have just performed a 2x2x2 fed state study with 26 volunteers on indapamide MR. This generic has already passed the fasting study a few years ago. The dissolution tests are ok.

❝ However in the fed study, the AUC passed, but the Cmax failed:

Can you tell us how successful you were in passing the fasting study? Wth flying colors or borderline?

Thanks

JOhn

Complete thread:

Failed Fed study on Indapamide MR Clarc 2013-11-19 11:04
- Failed Fed study on Indapamide MR Dr_Dan 2013-11-19 14:31
- Failed Fed study on Indapamide MR ElMaestro 2013-11-19 15:56
  - CV from CI Helmut 2013-11-19 16:42
    - CV from CI ElMaestro 2013-11-19 16:59
      - Misprint gremlin Helmut 2013-11-19 17:05
  - Failed Fed study on Indapamide MR Clarc 2013-11-20 07:28
- Failed Fed study on Indapamide MRjag009 2013-11-19 19:45
  - Failed Fed study on Indapamide MR Clarc 2013-11-20 07:36
    - Failed Fed study on Indapamide MR luvblooms 2013-11-20 08:51
      - Failed Fed study on Indapamide MR Clarc 2013-11-20 10:59
        
        Failed Fed study on Indapamide MR jag009 2013-11-20 17:30
        Failed Fed study on Indapamide MR luvblooms 2013-11-21 06:00
        
        Failed Fed study on Indapamide MR Clarc 2013-11-21 07:11

Failed Fed study on Indapamide MR [Study As­sess­ment]

Complete thread:

Failed Fed study on Indapamide MR [Study Assessment]