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RegisterDutasteride, Tamsulosin study [Design Issues]
Dear All,
Please suggest..
The terminal elimination half-life of dutasteride is approximately 5 weeks at steady state.
In the available literature studies were crossover, truncated with a washout of 45 days. we are not confident on the wash out as half life much longer.
With the above senario, if we go with a parallel design (suggested by FDA guidance 2014) the reported inter subject variability for Dutasteride is > 50 %, resulted sample size is 78 per arm (with 80 % power and 100 % T/R ratio.
In above case if we end up with high power for Tamsulosin, is there any chance to make a cut off in sample size for estimation of tamsulosin or else we need to estimate tamsulosin also in all the subjects.
Regards,
naveen kumar. SR
Edit: Category changed. [Helmut]
Please suggest..
The terminal elimination half-life of dutasteride is approximately 5 weeks at steady state.
In the available literature studies were crossover, truncated with a washout of 45 days. we are not confident on the wash out as half life much longer.
With the above senario, if we go with a parallel design (suggested by FDA guidance 2014) the reported inter subject variability for Dutasteride is > 50 %, resulted sample size is 78 per arm (with 80 % power and 100 % T/R ratio.
In above case if we end up with high power for Tamsulosin, is there any chance to make a cut off in sample size for estimation of tamsulosin or else we need to estimate tamsulosin also in all the subjects.
Regards,
naveen kumar. SR
Edit: Category changed. [Helmut]
Complete thread:
- Dutasteride, Tamsulosin studyNaveen Kumar 2014-07-23 10:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dutasteride, Tamsulosin study Dr_Dan 2014-07-23 11:47
Ing. Helmut Schütz