Rosy
☆    

Mexico,
2020-03-21 23:38
(258 d 23:35 ago)

Posting: # 21293
Views: 1,444
 

 Dextromethorphan [Study Per­for­mance]

Hello Everyone,

Please help me, i was trying to found information about variability of dextromethorphan, but i only find some chinese articles that i can't download or purchase. I also found an inform from Boehringer Ingelheim "A phase I, single dose, controlled two-way crossover trial to evaluate the relative bioavailability of orally administered dextromethorphan syrup (21 mg dextromethorphan hydrobromide monohydrate) in comparison to dextromethorphan soft pastilles (21 mg dextromethorphan hydrobromide monohydrate) in healthy male and female subjects who are extensive metabolisers for cytochrome P450 (CYP) 2D6" but i think that it's so risky to use the variability from this study.
I forgot to mention that i need to evaluate soft capsules of dextromethorphan, and the sponsor refuses to run a pilot.

thank u for read me.
pmohite
☆    

India,
2020-06-08 08:49
(180 d 15:23 ago)

@ Rosy
Posting: # 21508
Views: 439
 

 Dextromethorphan

Hello,

Be study data on dextromethorphan is rarely available in public domain.

However, if you look in the FDA review for dextromethorphan, you can get the intra subject variability and BE study design.

Look for BE review with application number as "ANDA 091135Orig1s000".

Regards


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Ohlbe]
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