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Hello Members,
Currently, i am involving in Quetiapine pharmacokinetic study. I need
to know the following
a). Like clozapine study, bioequivalence study of quetiapine has to
be conducted in schizopherenic patients or else it can be done in
healthy volunteers.
b) It reaches state state concentration in two days time accoring to
the literature. Can I design the multiple dose dose study for 5 days.
3rd and 4th day, i can confirm the steady state concentration and 5th
day pharmacokinetic study. Is it O.K?.
Kindly provide the details.
Regards,
Francis
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The following message was posted to: PharmPK
Main reason for doing Clozapin studies in schizophrenic patients are
side effects, like agranulozytosis, which prohibit study performance
in healthy volunteers. We did a couple of studies in schizophrenic
patients and they are not unproblematic, mainly for ethical reasons.
The side effects reported for Clozapin were - to my knowledge - not
described for Quetiapine. So I do not see a reason not to perform the
study in healthy volunteers.
The design described by you seems to be reasonable.
With best regards,
Christian Reh
Pharmacon Research GmbH
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The pharmacokinetics of quetiapine have been characterised in healthy
volunteers using low doses (10 to 25mg)
See: DeVane and Nemeroff. Clinical pharmacokinetics of quetiapine:
an atypical antipsychotic. Clin Pharmacokinet 2001; 40: 509-22
The usually recommended dose for schizophrenia is much higher (300 to
450 mg in two divided doses)
I doubt healthy volunteers would be able to tolerate well clinically
relevant doses
Regards
Gianluca
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Dear Gianluca,
Thank you for the information. Now I have a concern that we have 2
listed RLDs as 25mg and 300mg. As per your comment 25mg bio in
healthy volunteers will not be a major issue but what about 300mg.
Shall we anticipate any specific problems and keep solutions ready
for the same or do we need to have any specific study design with
some specific precautions.
Any insight will be great help.
Regards
Manoj K. Paruthi
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Dear Members,
Can anyone justify that why we have to conduct Quetiapine 300 mg
biostudy in patients?.I have seen it in the literatutre that 300 mg
studies have been conducted in patients.( It's quite evident that
25mg Quetiapine study was performed in healthy volunteers).
Regards,
Francis
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