regimen; no./time TT087190 Rat (SD); Embryofetal 30 30.9 2.2 6 over development 0.5–24 h; 150 279 19.5 = 3 ♀ 1000 853 59.7 TT107100 Rat (SD); Embryofetal 30 76.8 5.4 6 over development 0.5–24 h; Suvorexant 80 230 16.1 n = 6 ♀ 325 794 55.5 Embryofetal 30 6.16 0.6 development M9 80 11.3 1.2 325 24.0 2.5 TT087200 Rabbit Embryofetal 40 29.9 2.1 (DB); development 6 over 100 95.7 6.7 0.5–24 h; n = 3 ♀ 300 255 17.8 TT107090 Rabbit Embryofetal 50 46.6 3.3 (DB); development 6 over Suvorexant 150 361 25.2 0.5–24 h; n = 6 ♀ 325 647 45.2 Embryofetal 50 57.6 6.0 development M9 150 234 24 325 314 33 TT117220 Rat (SD); Pre/postnatal 200 447 31.3 6 over development 0.5–24 h; Suvorexant n = 6 ♀ Pre/postnatal 200 20.6 2.2 development M9 Human Steady 40 mg (healthy state 14.3# volunteers) M9: 9.55& ^ = animal: human plasma AUC0–24 h for suvorexant and M9 # = Module 2.7.2, Summary of Clinical Pharmacology Studies, Tables 38-40 & = Reference P003, Day 14 data
regimen; no./time TT087190 Rat (SD); 6 over 0.5–24 h; = 3 ♀ Embryofetal development 30 30.9 2.2 150 279 19.5 1000 853 59.7 TT107100 Rat (SD); 6 over 0.5–24 h; n = 6 ♀ Embryofetal development Suvorexant 30 76.8 5.4 80 230 16.1 325 794 55.5 Embryofetal development M9 30 6.16 0.6 80 11.3 1.2 325 24.0 2.5 TT087200 Rabbit (DB); 6 over 0.5–24 h; n = 3 ♀ Embryofetal development 40 29.9 2.1 100 95.7 6.7 300 255 17.8 TT107090 Rabbit (DB); 6 over 0.5–24 h; n = 6 ♀ Embryofetal development Suvorexant 50 46.6 3.3 150 361 25.2 325 647 45.2 Embryofetal development M9 50 57.6 6.0 150 234 24 325 314 33 TT117220 Rat (SD); 6 over 0.5–24 h; n = 6 ♀ Pre/postnatal development Suvorexant 200 447 31.3 Pre/postnatal development M9 200 20.6 2.2 Human (healthy volunteers) Steady state 40 mg 14.3# M9: 9.55& ^ = animal: human plasma AUC0–24 h for suvorexant and M9 # = Module 2.7.2, Summary of Clinical Pharmacology Studies, Tables 38-40 & = Reference P003, Day 14 data
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