Diclofenac SR fast or fed state study design [Design Issues]

posted by xtianbadillo – Mexico, 2018-03-16 16:26 (2255 d 22:07 ago) – Posting: # 18562
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❝ ❝ Recommended studies: 2 studies : does it mean that both should be perofrmed??


Yes, you have to perform both studies. There are some recommendations.

1) Two cross-over, One study should be conducted under fasting conditions and the other after-meal intake at a specific time before the administration of the treatment.

2) A study cross-over, with four periods, with four sequences for four treatments. Both the test medication and the reference medicine should be evaluated under fasting conditions and after food intake at a specific time before the administration of the treatment.

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