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Table 1 The effects of ketoconazole and clarithromycin on riociguat pharmacokinetics (geometric means and coefficients of variation)

From: Pharmacokinetic interaction of ketoconazole, clarithromycin, and midazolam with riociguat

 

Riociguat/ketoconazole study

Riociguat/clarithromycin study

Parameter

Riociguat 0.5 mg (n=16)

Riociguat 0.5 mg + ketoconazole (n=16)

Riociguat 1 mg (n=14)

Riociguat 1 mg + clarithromycin (n=14)

 

GM

%CV

GM

%CV

GM

%CV

GM

%CV

AUC (µg·h/L)

81.9

78.6

204.9

44.9

171.1

97.0

240.0

88.9

Cmax (µg/L)

9.4

29.9

13.7

19.3

20.8

37.7

21.6

33.9

t1/2 (h)

7.3

78.5

9.2

57.1

6.4

77.1

7.9

54.6

CL/f (L/h)

6.1

78.6

2.4

44.9

5.8

97.0

4.2

88.9

  1. AUC, area under plasma concentration–time curve; CL/f, total riociguat clearance from plasma; Cmax, maximum riociguat plasma concentration; CV, coefficient of variation; GM, geometric mean; t1/2, elimination half-life.