TABLE 5

Metabolite pattern in plasma, urine, and feces after p.o. administration of 200 mg of [14C]dabigatran etexilate in healthy volunteers

Data are mean percentage recovery from five individuals.


Metabolite

Synthetic Reference

Plasma (2, 4, and 6 h)

Urine (0-48 h)

Feces (main fractions)
M354 Trace amountsa
M369 0.5% 0.4%
M324 BIBR1151 Trace amountsa 0.4% 2.3%
M355 BI00003521 Trace amountsa 0.6% 0.6%
M325 CD00000338 0.3%
M396 BI00003522 Trace amountsa 0.1% 0.1%
M500(1) Trace amountsa Trace amountsa
M531 Trace amountsa
M574 Trace amountsa
M472 Dabigatran 100.0% 4.3% 66.1%
M648 + M690 Trace amountsa,b 0.4%
M602 0.5%
M636 <0.1%
M630 0.1% 0.2%
M488 Trace amountsa 0.1% 1.2%
M614 Trace amountsa Trace amountsa
M400 BI00003543 0.2% 5.8%
M616 <0.1% 2.0%
M600 BIBR1087 Trace amountsa 0.2%
M628 Dabigatran etexilate Trace amountsa
Subtotal

100.0%
7.1%
79.4%
  • a Detected by LC/MS, <LOD of HPLC/radioactivity detection.

  • b M648 only; M690 not present.