Fasting and Fed Study [Design Issues]

posted by Phaneendra.K – 2011-09-10 19:20 (5398 d 16:10 ago) – Posting: # 7345
Views: 4,321

Dear all,

What is the Rationale for designing a study in
1. fasting condition alone
2. fed condition alone
3. fasting and fed conditions?
Which factors are taken into account for this?

Montelukast Sodium film coated tablets are assesed for BE with Singulair, in both fasting and fed states. It's neither narrow therapeutic drug, nor a modified release formulation.Why is fed study not waived here?

Thanks and Regards,

PK

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