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In a mouse carcinogenicity study in modafinil which armodafinil (the R-enantiomer of modafinil) was administered at oral doses of up to 300 mg/kg/day in males and 100 mg/kg/day in females for approximately 2 years, no tumorigenic effects were observed .
The highest doses studied, which were considered MTDs, were associated with plasma armodafinil exposures less than modafinil (females) or 2 times (males) that in humans at the RHD of PROVIGIL .
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