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RegisterBE study on FDC of Niacin ER+Lovastatin [Design Issues]
Dear Forum,
Kindly provide us your valuable suggestions and views.
BE study for FDC of Niacin ER+Lovastatin, OGD has recommended total five studies under fasting and fed conditions in healthy volunteers.
But, according to Prescribing Information (dosage and administration) dosing is recommened at bedtime and after low fat snacks. (low fat snacks to reduce flushing, pruritus and GI distress).
Innovator has conducted all the studies after low fat snacks (which is not purely fasting condition) and dosing at bed time in volunteers of 40-70 years of age group.
Please share your views for the study design (fasting or low fat snacks) and selection of volunteers wrt to age.
Kindly provide us your valuable suggestions and views.
BE study for FDC of Niacin ER+Lovastatin, OGD has recommended total five studies under fasting and fed conditions in healthy volunteers.
But, according to Prescribing Information (dosage and administration) dosing is recommened at bedtime and after low fat snacks. (low fat snacks to reduce flushing, pruritus and GI distress).
Innovator has conducted all the studies after low fat snacks (which is not purely fasting condition) and dosing at bed time in volunteers of 40-70 years of age group.
Please share your views for the study design (fasting or low fat snacks) and selection of volunteers wrt to age.
—
Dr. Hiren Mehta
Dr. Hiren Mehta
Complete thread:
- BE study on FDC of Niacin ER+Lovastatinhirenpharm 2009-03-13 11:32
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz