Bioequivalence and Bioavailability Forum • clopidogrel bioequivalence

clopidogrel bioequivalence - PD endpoint [Design Issues]

posted by drdds – 2007-06-04 11:08 (6960 d 10:22 ago) – Posting: # 773
Views: 10,413

Dear Kshitij,

Clopidogrel is rapidly absorbed after oral administration, with peak plasma levels of the main circulating metabolite occurring approximately 1 hour after dosing. The pharmacokinetics of the main circulating metabolite are linear (plasma concentrations increased in proportion to dose) in the dose range of 50 to 150 mg of clopidogrel. Absorption is at least 50% based on urinary excretion of clopidogrel-related metabolites.

Cmax (µg/ml) 6.66±1.70
Tmax (hours) 2.31±0.91
t½ (hours) 6.94±2.76

so i believe the PD is not the solution.

DDS.

Complete thread:

clopidogrel velupharm 2007-03-30 16:58
- clopidogrel Ohlbe 2007-03-30 17:44
- clopidogrel Imran 2007-04-11 10:54
- clopidogrel bioequivalence - PD endpoint drks 2007-05-29 07:53
  - clopidogrel bioequivalence - PD endpoint Helmut 2007-05-29 11:47
    - clopidogrel bioequivalence - PD endpoint drks 2007-05-30 10:13
      - clopidogrel bioequivalence - PD endpoint Helmut 2007-05-30 12:47
    - clopidogrel bioequivalence - PD endpoint lukamar 2009-01-13 11:56
      - clopidogrel bioequivalence - PD endpoint lukamar 2009-01-19 10:33
        
        clopidogrel active metabolite Ohlbe 2009-01-21 23:42
        
        Current EU-position Helmut 2009-07-31 14:24
        
        Supportive data? ElMaestro 2009-07-31 19:10
        
        Supportive data? Helmut 2009-07-31 19:39
        
        Supportive data? Ohlbe 2009-07-31 19:48
    - clopidogrel bioequivalence - PD endpoint lukamar 2009-01-13 12:35
      - clopidogrel bioequivalence - PD endpoint Helmut 2009-01-14 14:33
      - clopidogrel bioequivalence - PD endpoint Ohlbe 2009-01-17 17:57
  - clopidogrel bioequivalence - PD endpointdrdds 2007-06-04 09:08
  - clopidogrel bioequivalence - PD endpoint ElMaestro 2009-01-14 17:22