DN04043 3 months 5 46 105 0.17 0.2 50 357 816 1.29 1.6 200 1135 2591 4.1 5 DN05030 6 months 5 40 91 0.143 0.2 [pivotal] 25 200 457 0.72 0.9 150 1024 2337 3.7 5 DN01103 6 months 15 99 226 0.36 0.4 75 409 935 1.47 1.8 150 844 1927 3.04 4 DN06073 2 years 0.5 3.6 8 0.013 0.02 [carc.] 2 14 32 0.050 0.06 10 74 169 0.266 0.33 Dog DN03050 1 month 5 62 142 3.3 4 (Beagle) 25 351 800 19 23 250 2265 5172 120 150 3 months 5 70 159 3.7 5 30 560 1277 30 37 180 2258 5154 120 149 DN05031 12 months 5 52 118 2.7 3.4 [pivotal] 20 230 525 12.2 15 120 1265 2888 67 83 Human Single dose 10 mg 0.438 0.803 – – Effect on food and water consumption and body weight changes Treatment with dapagliflozin increased water consumption and urine output at all doses tested in rats and dogs. These parameters were not assessed in the mouse toxicity studies
DN04043 3 months 5 46 105 0.17 0.2 50 357 816 1.29 1.6 200 1135 2591 4.1 5 DN05030 [pivotal] 6 months 5 40 91 0.143 0.2 25 200 457 0.72 0.9 150 1024 2337 3.7 5 DN01103 6 months 15 99 226 0.36 0.4 75 409 935 1.47 1.8 150 844 1927 3.04 4 DN06073 [carc.] 2 years 0.5 3.6 8 0.013 0.02 2 14 32 0.050 0.06 10 74 169 0.266 0.33 Dog (Beagle) DN03050 1 month 5 62 142 3.3 4 25 351 800 19 23 250 2265 5172 120 150 3 months 5 70 159 3.7 5 30 560 1277 30 37 180 2258 5154 120 149 DN05031 [pivotal] 12 months 5 52 118 2.7 3.4 20 230 525 12.2 15 120 1265 2888 67 83 Human Single dose 10 mg 0.438 – 0.803 – Effect on food and water consumption and body weight changes Treatment with dapagliflozin increased water consumption and urine output at all doses tested in rats and dogs. These parameters were not assessed in the mouse toxicity studies
auspar-dapagliflozin-propanediol-monohydrate-130114.docx