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In an mbyo-tal dvlopmnt study, pgnant hsus monkys w xposd intavnously ta dutastid blood lvl compaabl tth dutastid concntation ound in human smn. Dutastid was administd on gstation days 20 t100 at doss 400, 780, 1,325, 2,010 ng/day (12 monkys/goup). Th dvlopmnt mal xtnal gnitalia monky osping was not advsly actd. duction tal adnal wights, duction in tal postat wights, and incass in tal ovaian and tstis wights w obsvd at th highst dos tstd in monkys. Basd on th highst masud smn concntation dutastid in tatd mn (14 ng/mL), ths doss psnt 0.8 t16 tims th potntial maximum xposu a 50-kg human mal t5 mL smn daily om a dutastid-tatd man, assuming 100% absoption. (Ths calculations a basd on blood lvls pant dug which a achivd at 32 t186 tims th daily doss administd tpgnant monkys on a ng/kg basis). Dutastid is highly bound tpotins in human smn (gat than 96%), potntially ducing th amount dutastid availabl vaginal absoption. It is not known whth abbits hsus monkys poduc any th majhuman mtabolits.
Bcaus clinical tials a conductd und widly vaying conditions, advs action ats obsvd in th clinical tials a dug cannot b dictly compad with ats in th clinical tial anoth dug and may not lct th ats obsvd in pactic.
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