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Hi,
i am designing a bioequivalence study, and the drug under investigation
is gabapentin. some studies indicate that proteins might affect
favourably its absorbtion. so i would like to get an opinion regarding
whether i should conduct a fasting bioequivalence study or a fed BE
study? i would highly appreciate your help on this matter.
regards
alexia attard (B.pharm student)
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Dear Alexia,
Since you are planning this study and you are aware that gabapentin's
bioavailability is affected by protein I would suggest you to take up
the study in fasted subjects, but if you will take up the study in fed
subjects also they will consume the same food with the same level of
calories in other words give them the same food as it was given before
the cross-over.
Therefore, the variability due to food might not affect the
bioavailability of the drug.
Thanks and regards
Dr. Shahid Karim
Sr. Research Scientist
Dabur Research Foundation
India.
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