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RegisterPrasugrel [Power / Sample Size]
Hi
For all who want to know more about prasugrel bioavailability and hints for bioequivalence I suggest:
Seiler D, Doser K, Salem I.: Relative bioavailability of prasugrel free base in comparison to prasugrel hydrochloride in the presence and in the absence of a proton pump inhibitor. Arzneimittelforschung. 2011;61(4):247-51.
Please be advised that if lansoprazole is used to raise the pH level in the upper gastro-intestinal tract, AUC is decreased by 25% after administration of prasugrel hydrochloride and by 41% after prasugrel free base. In addition, the peak plasma levels are decreased by 52% and 72%, respectively (geom. means). The relative bioavailability of the prasugrel free base compared to prasugrel hydrochloride, both in the presence and in the absence of the proton pump inhibitor lansoprazole, differs so much that most probably a generic formulation containing prasugrel free base will not be equivalent in all aspects to the originator product.
Kind regards
Dan
For all who want to know more about prasugrel bioavailability and hints for bioequivalence I suggest:
Seiler D, Doser K, Salem I.: Relative bioavailability of prasugrel free base in comparison to prasugrel hydrochloride in the presence and in the absence of a proton pump inhibitor. Arzneimittelforschung. 2011;61(4):247-51.
Please be advised that if lansoprazole is used to raise the pH level in the upper gastro-intestinal tract, AUC is decreased by 25% after administration of prasugrel hydrochloride and by 41% after prasugrel free base. In addition, the peak plasma levels are decreased by 52% and 72%, respectively (geom. means). The relative bioavailability of the prasugrel free base compared to prasugrel hydrochloride, both in the presence and in the absence of the proton pump inhibitor lansoprazole, differs so much that most probably a generic formulation containing prasugrel free base will not be equivalent in all aspects to the originator product.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Fasting vs Fed study sam 2012-11-26 09:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Prasugrel Helmut 2012-11-26 13:48
- Prasugrel lukamar 2012-11-26 15:13
- Prasugrel Helmut 2012-11-26 15:30
- Prasugrel sam 2012-11-27 12:52
- PrasugrelDr_Dan 2012-11-27 14:19
- Different ka and f Helmut 2012-11-27 14:56
- Different ka and f? d_labes 2012-11-28 12:10
- Sorry. Forget it. Helmut 2012-11-28 15:42
- R code gem d_labes 2012-11-28 16:23
- R code gem Helmut 2012-11-28 16:54
- R code gem d_labes 2012-11-28 16:23
- Sorry. Forget it. Helmut 2012-11-28 15:42
- Different ka and f sam 2012-11-28 12:38
- Different ka and f jag009 2012-11-29 16:30
- Different ka and f? d_labes 2012-11-28 12:10
- Prasugrel jag009 2012-11-28 22:31
- Prasugrel sam 2012-11-29 04:57
- Prasugrel lukamar 2012-11-26 15:13
- Fasting vs Fed study drgunasakaran1 2012-11-27 14:17
- For EU submission of Prasugrel venkata krishna 2013-02-23 06:40
- EU: parent Helmut 2013-02-23 12:07
- For EU submission of Prasugrel venkata krishna 2013-02-23 06:40
- Prasugrel Helmut 2012-11-26 13:48
Ing. Helmut Schütz