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Dear All,
I need an indication of intra-subject CVs for Lisinopril (Cmax and AUC)
for a sample
size estimate. Please share your experience.
Thank you
Hannes Breedt
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The following message was posted to: PharmPK
Dear Hannes Breedt
Please find below the statistical analysis performed for two
bioequivalence
studies of lisinopril.
n intra-subject CV Power Ratio C.I. 90%
Cmax
lisinopril - 20 mg - tablet 26 26.58% 0.83 92.63 81.65 105.09
lisinopril - 30 mg - tablet 29 26.85% 0.86 91.92 81.51 103.65
AUC last
lisinopril - 20 mg - tablet 26 24.65% 0.88 95.51 84.97 107.37
lisinopril - 30 mg - tablet 29 26.90% 0.86 93.03 82.48 104.94
Therefore, thirty volunteers are enough to demonstrate whether the
lisinopril formulations are bioequivalent for the rate and the extent of
absorption.
Best regards,
Gustavo.
Gustavo Duarte Mendes, DDS, Phill
Bio statistics Manager
Cartesius Desenvolvimento de Pesquisas Clínicas Ltda.
Campinas - SP- BRAZIL
Phone: 55-19-3251 6928
Fax: 55-19-3252 1516
www.cartesius.com
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The following message was posted to: PharmPK
Dear Hannes Breedt,
below some more data confirming Gustavo Duarte Mendes'.
All studies on lisinopril tablets in 24 subjects, analytics by GC/MS
with stable isotope internal standardization, intra subject CV% from
ANOVA of log transformed data:
20 mg single dose
AUCinf 25.90
Cmax 32.44
Cmax/AUCinf 13.68
10 mg single dose
AUCinf 21.31
Cmax 26.63
Cmax/AUCinf 8.98
2.5 mg steady state
AUC24h 10.51
Cmax 17.37
Cmax/AUC24 10.14
%PTF 16.41
Lisinopril shows the well known effect of reduction of variability in
steady state.
Best regards,
Helmut
Helmut Schütz Biokinet GmbH / Dept Biostatistics
Neubaugasse 36/11 Nattergasse 4
A-1070 Vienna/Austria A-1170 Vienna/Austria
tel/fax +43 1 9713935 tel +43 1 4856969 62
no cell phone ;-) fax +43 1 4856969 90
http://www.goldmark.org/netrants/no-word/attach.html
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