madhavaraob
☆    

2010-07-14 13:49
(5810 d 09:23 ago)

Posting: # 5622
Views: 7,026
 

 BE study of Venlafaxine XR capsules in fasting state [Study Per­for­mance]

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Dear all,

We are planning to conduct a BE study of Venlafaxine XR capsules for Brazil submission. US-FDA recommends to conduct Bioequivalence study of Venlafaxine XR capsules only in fed conditions because of safety issues in fasting state. I would like to know about the safety concerns when dosed in fasting conditions. Is it reliable to carry out BE study for the said drug in fasting conditions? Can anyone provide me any data on safety issues for justifying the non conductance of BE study in fasting state.

Thanking You in anticipation.

Regards,
Madhav Rao
 
d_labes
★★★

Berlin, Germany,
2010-07-14 15:28
(5810 d 07:43 ago)

@ madhavaraob
Posting: # 5623
Views: 5,771
 

 Nausea, vomitting, dizziness ...

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Dear Madhav,

please :google:. Keywords: venlafaxin fasting bioequivalence
First hit page gives you this an more ...
—
Regards,

Detlew
 
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