Diclofenac Potassium Powder for Oral Solution [Regulatives / Guidelines]

posted by mayur661 – India, 2018-11-16 10:08 (749 d 14:19 ago) – Posting: # 19637
Views: 13,206

Dear Ohlbe,

» In which country do you intend to submit your data ? Guidelines and requirements vary from one region to the next.

We are intending to submit data to USA.

Dear Members,
In Package insert of diclofenac potassium for Oral solution it mentioned that
''High fat food had no significant effect on the extent of diclofenac absorption, but there was a reduction in peak plasma levels of approximately 70% after a high fat meal. Decreased Cmax may be associated to decreased effectiveness''. ''Taking CAMBIA with food may cause a reduction in effectiveness compared to taking CAMBIA on an empty stomach'' As per these statements we are going for only fasting BE study. Please provide opinion on this topic.

Thanks lot

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post!
Two successive posts merged. You can edit your messages within 24 hours from posting a message [Ohlbe]

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