Bioequivalence and Bioavailability Forum • DDI only in steady state

DDI only in steady state [Design Issues]

posted by Dr_Dan – Germany, 2015-01-07 16:42 (4185 d 21:39 ago) – Posting: # 14238
Views: 9,607

Hi Helmut
I am facing the problem of a DDI with two drugs of very different half-lives (even much bigger difference than your example) and I am wondering if it would be possible to use a sequential design instead of the randomised cross-over. According to my understanding this should be in agreement with the Guideline. The sequence of treatments would be just CBA with C=drug1, short half life, B=drug2, long half life and A=FDC, all treatments in steady state. The advantage would be a reduced study duration and some cost savings. What would be the disadvantages and/or pitfalls?
Any idea?
Looking forward to your or anybody else´s reply.
Kind regards
Dr_Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

drug-drug interaction in steady state? Dr_Dan 2014-12-08 17:31
- DDI only in steady state Helmut 2014-12-08 17:43
  - DDI only in steady state Dr_Dan 2014-12-08 18:15
    - DDI only in steady state Helmut 2014-12-08 18:30
      - DDI only in steady state felipeberlinski 2014-12-18 17:37
        
        DDI only in steady state Helmut 2014-12-18 17:59
      - DDI only in steady stateDr_Dan 2015-01-07 15:42
        
        DDI active wash-out Dr_Dan 2015-01-09 12:04
        
        DDI active wash-out nobody 2015-01-09 15:03
        DDI active wash-out Dr_Dan 2015-01-09 15:59
        
        DDI active wash-out nobody 2015-01-09 16:38