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RegisterBE study of Venlafaxine XR capsules in fasting state [Study Performance]
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
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
Complete thread:
- BE study of Venlafaxine XR capsules in fasting statemadhavaraob 2010-07-14 11:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Nausea, vomitting, dizziness ... d_labes 2010-07-14 13:28
Ing. Helmut Schütz