Bioequivalence and Bioavailability Forum • Clopidogrel

Clopidogrel [Design Issues]

posted by Rahul – India, 2009-05-27 10:47 (6235 d 08:53 ago) – Posting: # 3772
Views: 4,784

Dear All,

We are planing to do Bioequivalence study of Clopidogrel 300 mg Table.

I had read back posts regarding PD endpoint of clopidogrel.

As Tmax of clopidogrel is around 45 mins and is detected in the body for almost 2 hrs,

is it necessary to do sampling upto 24 hrs? (Single-dose randomized, open-label, 2-way crossover bioequivalence study of clopidogrel 75 mg tablet in healthy volunteers under fasting conditions. Filipe A, Almeida S, Franco Spínola AC, Neves R, Tanguay M, Jiménez C, Shink E; Int J Clin Pharmacol Ther. 2009 Mar;47(3):187-94)
Active metabolite is non-detectable and as per recommendation we have to measure clopidogrel, so is it required to measure carboxylic acid inactive metabolite? if so, why?

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Thanks n regards,
Rahul...

Complete thread:

ClopidogrelRahul 2009-05-27 08:47
- Clopidogrel hirenpharm 2009-05-27 12:43
- Clopidogrel Helmut 2009-05-27 13:31
  - Clopidogrel Rahul 2009-05-28 12:29