Which Tmax to be consider in case of b.i.d. dosing? [NCA / SHAM]

posted by maulik963 – India, 2016-04-13 08:06  – Posting: # 16194
Views: 3,854

Dear All,

I want to conduct 2-way crossover study with Extended Release (Once daily dosing regimen) Test product and Immediate Release (Two times a day dosing regimen) Reference Product.

Study design is 2-Treatment, 2-period, 2-sequence, single dose of Test product vs. multiple dose of Reference product at 12.0 hours interval.

Considering above details, I need answer/clarification on the below point.

As Reference product is to be given two times a day at 12.00 hours interval, there will be total two Cmax (means two Tmax where maximum concentration achieved).

So which Tmax should be consider? (i.e. The Tmax reported after first dosing or Tmax which is actually a highest value among the two Tmax).

Please note that the molecule does not have the property of giving two distinct peak after single dosing.

Thanks in advance.


Edit: Category changed. [Helmut]

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