maverick
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India,
2009-10-06 15:04
(6111 d 10:23 ago)

Posting: # 4300
Views: 4,976
 

 Levomepromazine [Design Issues]

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Dear All,
can anyone pass on the statistical details viz %CV, 90% CI for any pilot Pharmacokinetic BE study conducted on Levomepromazine maleate 25 mg tablets under fasted conditions?

Best Regards,
Maverick

Edit: Category changed. [Helmut]
 
Helmut
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Vienna, Austria,
2009-10-06 18:52
(6111 d 06:36 ago)

@ maverick
Posting: # 4305
Views: 4,335
 

 Levomepromazine

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Hi Maverick!

Sorry no 25 mg, but one example (100 mg, n=12) may serve as a starting point:

Bagli et al.
Bioequivalence and absolute bioavailability of oblong and coated levomepromazine tablets in CYP2D6 phenotyped subjects
Int J Clin Pharmacol Ther 33/12, 646-652 (1995)

From the reported CIs I calculate a CVintra of ~25% for AUCinf and ~28% for Cmax.
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