Bioequivalence and Bioavailability Forum

Hi Eswar!

❝ Dear all can any one tell me about is it possible to do fasting BE Study

❝ for the venlafaxine extended release 150mg capsule for USFDA submission.

❝ As fer my knowledge higest strength available in market should be done Fed

❝ condition (Fda submision).for fasting condition please give me any refrence

❝ are available information

http://www.fda.gov/cder/guidance/5356fnl.pdf Quoting the FDA (March 2003):
For modified-release products submitted as ANDAs, the following studies are recommended:
(1) a single-dose, nonreplicate, fasting study comparing the highest strength of the test and reference listed drug product and
(2) a food-effect, nonreplicate study comparing the highest strength of the test and reference product.

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Edit: Link corrected to latest archived copy. [Helmut]

Dear Eswar,

Please do not do fasting study for any strength of venlafaxine. Kindly see the literature on administration of venlafaxine. It should be given only with food. We have extensive experience on venlafaxine biostudies. The major adverse event if it is administered in empty stomach is heavy nausea and eventually vomiting. This is not an easy molecule.

Regards

Dr. Shiv

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Edit: Full quote removed. [HS]

Dear eswar

As far as Venlafaxine ER capsule is considered (ANDA), FDA has recommended us to do only fed state single dose study with 150 mg. In addition, if your formulation can be sprinkled over soft food, then you have to carry a Sprinkle study in fed state.

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Edit: Capitals reformatted to bold. [HS]