Bioequivalence and Bioavailability Forum

Failed Fed study on Indapamide MR [Study Assessment]

posted by Clarc – Romania, 2013-11-19 12:04 (4599 d 05:22 ago) – Posting: # 11911
Views: 16,092

Dear all

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:

AUC:

Reference Confidence Interval:            [  0.8,      1.25   ]


Geomean Ratio (Test/Reference) = 0.930233

90% standard confidence interval

(around the ratio:[test form]/[ref form])=[  0.83186,  1.0402 ]


t(0.05 - 24df) = 1.7109

Cmax

Reference Confidence Interval:            [  0.8,      1.25   ]


Geomean Ratio (Test/Reference) = 0.680132

90% standard confidence interval

(around the ratio:[test form]/[ref form])=[  0.61796,  0.74855]


t(0.05 - 24df) = 1.7109

In your opinion this failure of Cmax is caused by the formulation, or is there something else with influence on our results?

Thanks

Edit: Category changed. [Helmut]

—
I'm always tryin' to do something new, tryin' to look like a beginner.
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Complete thread:

Failed Fed study on Indapamide MRClarc 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 MR jag009 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]