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The following message was posted to: PharmPK
Dear All,
Anybody worked on Bioequivalence of Amodiaquine. Should it be
parallel or cross-over? How many volunteers?
Regards
Dr Ashish Mungantiwar
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The following message was posted to: PharmPK
I am currently working on the Bioeequivalence of
Amodiaquine and I am using the crossover method
Dr Grace Ukpo
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The following message was posted to: PharmPK
Dear Dr Grace Ukpo,
Thanks for your comment. However, I would like to add my observations
Amodiaquine has an active metabolite (desethyl Amodiaquine) having
half life of 9-31 days. The half life of Amodiaquine is 5.2 hrs. So,
even if we take minimum half life of 9 days for active metabolite,
the wash out period will be 45 days and time collection will be 27
days. Thus, in order to complete a study, it will take 2.5 months for
clinical. Hence in this situation should we prefer cross over.
Guidelines do mention that if wash period exceeds 4 weeks parallel
design may be considered.
Regards
Dr Ashish Mungantiwar
General Manager -Medical Services &
Head- Bioequivalence Study
Macleods Pharmaceuticals Limited, India
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