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INCIVEK(telaprevir)tablet, film coated(二十一)
2013-10-12 22:46:53 来源: 作者: 【 】 浏览:17914次 评论:0
ir PK†
LS Mean Ratio (90% CI) of Telaprevir PK With/Without Co-administered Drug
Drug Telaprevir Cmax AUC or Cavg,ss Cmin
NA: not available/ not applicable; N = Number of subjects with data; qd = once daily; bid = twice daily; q8h = every 8 hours; q12h = every 12 hours
*
Data provided are under fed conditions unless otherwise noted.
The direction of the arrow (↑ = increase,= decrease,= no change) indicates the direction of the change in PK
Cavg,ss = Average concentrations at steady state (AUCτ/τ).
§
Value with co-administered drug and telaprevir / value with telaprevir 750 mg q8h alone
Escitalopram 10 mg qd for 7 days 750 mg q8h for 14 days 13 1.00
(0.95; 1.05)
0.93
(0.89; 0.97)
0.91
(0.86; 0.97)
Esomeprazole 40 mg qd for 6 days 750 mg single dose 24 0.95
(0.86; 1.06)
0.98
(0.91; 1.05)
NA
Ketoconazole Ketoconazole
400 mg single dose
750 mg single dose 17 1.24
(1.10; 1.41)
1.62
(1.45; 1.81)
NA
Oral Contraceptive Norethindrone/ ethinyl estradiol 0.5 mg/0.035 mg qd for 21 days 750 mg q8h for 21 days 23 1.00
(0.93; 1.07)
0.99
(0.93; 1.05)
1.00
(0.93; 1.08)
Rifampin 600 mg qd for 8 days 750 mg single dose 16 0.14
(0.11; 0.18)
0.08
(0.07; 0.11)
NA
Anti-HIV Drugs
Atazanavir (ATV)/ritonavir (rtv) 300 mg ATV/ 100 mg rtv qd for 20 days 750 mg q8h for 10 days 14 0.79
(0.74; 0.84)
0.80
(0.76; 0.85)
0.85
(0.75; 0.98)
Darunavir (DRV)/ritonavir (rtv) 600 mg DRV/ 100 mg rtv bid for 20 days 750 mg q8h for 10 days 11 (N=14 for Cmax) 0.64
(0.61; 0.67)
0.65
(0.61; 0.69)
0.68
(0.63; 0.74)
Efavir
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