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This is regarding the BE study of the combination of Lisinopril [5mg] +
Hydrochlorothiazide [12.5mg]. The innovator\0xEDs combination is Lisinopril
[10mg] + Hydrochlorothiazide [12.5mg].
We have received a remark from one of the regulatory that we should be
comparing our combination [5+12.5] with the innovator\0xEDs [i.e.10+12.5],
using dose normalization calculations. I doubt if this may be
acceptable, because one requires that both test and reference should be
in the same molar dose for a BE demonstration. I would be grateful if
any one of you who have come across such cases could comment.
We wish to compare our combination tablet with co-administration of
single preparations of Lisinopril tablet [5mg] and Hydrochlorothiazide
capsule [12.5mg] in a two way cross over fashion. Could the fact that
ours is a tablet formulation and one of the two actives [Comparator] is
a capsule formulation matter? If that is the case we would like to
compare double dose of our combination [2 x {5+12.5}] with innovator\0xEDs
Lisinopril Tablet [10mg] and Hydrochlorothiazide Tablet [25mg].
What could be the best option in such cases?
Regards
Kaushal Prajapati
Corporate Quality Assurance
Torrent Pharmaceuticals limited
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