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VICTRELIS(boceprevir) capsule(十七)
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Co-administered Drug Dose/Schedule |
Boceprevir Dose/Schedule |
Ratio Estimate of Boceprevir Pharmacokinetic Parameters (in Combination vs. Alone)
(90% CI of the Ratio Estimate) * |
Change in mean Cmax |
Change in mean AUC |
Change in mean Cmin |
N/A = not available |
|
Ketoconazole |
400 mg two times daily × 6 days |
400 mg single oral dose |
1.41
(1.00–1.97) |
2.31
(2.00–2.67) |
N/A |
Ibuprofen |
600 mg three times daily × 6 days |
400 mg single oral dose |
0.94
(0.67–1.32) |
1.04
(0.90–1.20) |
N/A |
Diflunisal |
250 mg two times daily × 7 days |
800 mg three times daily × 12 days |
0.86
(0.56–1.32) |
0.96
(0.79–1.17) |
1.31
(1.04–1.65) |
Ritonavir |
100 mg daily × 12 days |
400 mg three times daily × 15 days |
0.73
(0.57–0.93) |
0.81
(0.73–0.91) |
1.04
(0.62–1.75) |
Efavirenz |
600 mg daily × 16 days |
800 mg three times daily × 6 days |
0.92
(0.78–1.08) |
0.81
(0.75–0.89) |
0.56
(0.42–0.74) |
Tenofovir |
300 mg daily × 7 days |
800 mg three times daily × 7 days |
1.05
(0.98–1.12) |
1.08
(1.02–1.14) |
1.08
(0.97–1.20) |
Peginterferon alfa-2b |
1.5 mcg/kg subcutaneous weekly × 2 weeks |
400 mg three times daily × 1 week |
0.88
(0.66–1.18) |
1.00*
(0.89–1.13) |
N/A |
Table 7 Summary of the Effect of Boceprevir on Co-administered Drugs in Healthy Subjects or HCV Positive Genotype-1 Subjects
Co-administered Drug |
Co-administered Drug Dose/Schedule |
Boceprevir Dose/Schedule |
Ratio Estimate of Co-administered Pharmacokinetic Parameters (in Combination vs. Alone)
(90% CI of the Ratio Estimate) * |
Change in mean Cmax |
Change in mean AUC(τ) |
N/A = not available |
|
Midazolam |
4 mg single oral dose |
800 mg three times daily × 6 days |
2.77
(2.36–3.25) |
5.30
(4.66–6.03) |
Efavirenz |
600 mg daily × 16 days |
800 mg three times daily × 6 days |
1.11
(1.02–1.20) |
1.20
(1.15–1.26) |
Drosp |
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