Comparison of 2 SR tablets with 1 IR release tablet [Design Issues]

posted by venkatesan – 2009-07-31 11:07 (6170 d 22:50 ago) – Posting: # 3998
Views: 3,733

Dear All,

we are going to conduct study on 2 SR tablets (i.e 2 test products) comparing with IR product.

Dose (1) is 2*150 mg IR at morning 8 and after 12hrs 2nd dose under fed condition
Dose (2) is either of one test 300 mg ER at morning under fed condition.

Now the question is

1st dose is given under fed condition with morning breakfast. pls let me know is it neccesary to food before the second dose.
Note: literature says that the does not have any impact on the PK profile.

Please reply ASAP

Thanks & Regards

Venkatesan

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