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Phaneendra.K ☆ 2011-09-10 19:20 (5399 d 07:09 ago) Posting: # 7345 Views: 4,323 |
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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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naveenk2601 ● 2011-09-20 13:53 (5389 d 12:37 ago) @ Phaneendra.K Posting: # 7380 Views: 3,515 |
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Hi Phaneendra, Since I've been actively handling generic filings for Montelukast Sodium for my client I wanted to throw some light on the same. If you notice the SmPCs of the innovator product you'll find that the absolute bioavailability of the lower doses of the drug ie. 4 & 5 mg are affected significantly when administered along with food. While the BA of the higher strength is not affected by the presence or absence of food. Hence the BE study for the same is performed under both fed (for the lower strength 5 mg) and fasting (for the highest strength 10 mg) conditions. Though I'm not an expert in the conduct of BE, but to the best of my understanding of various guidelines the design of a BE study is largely dependent on the Food-Drug Interactions. In general, a drug known to have PK interactions with food is to be studied after feeding the subject with the food known to have the interaction. PS: I'm open to suggestions or improvement to my understanding of the subject. Request others in the forum to correct me if I'm wrong. Regards, Naveen Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
Ing. Helmut Schütz