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Table 2 Pharmacokinetic parameters of treprostinil in SSc patients following dose escalation to 2 mg and 4 mg BID.

From: Open label study of escalating doses of oral treprostinil diethanolamine in patients with systemic sclerosis and digital ischemia: pharmacokinetics and correlation with digital perfusion

Cohort

Regimen

Statistics

Cmax

(pg/mL)

tmax

(hour)

AUC(0-12)

(hr*pg/mL)

t½

(hour)

2 mg BID

(Number = 17)

GeoMean

CV%

Median

Mean

CVb%

Minimum

Maximum

1,063

51.1

1,190

1,176

43.6

428

2,200

na

na

4.0

3.58

74.3

0.0

12.0

6,400

56.9

6,764

7,187

45.2

2027

13,820

2.94

61.6

3.28

3.39

56.0

1.07

8.48

4 mg BID

(Number = 12)

GeoMean

CV%

Median

Mean

CVb%

Minimum

Maximum

1,895

52.8

1,930

2,107

46.3

752

3,950

na

na

4.0

3.67

31.5

2.0

6.0

11,880

45.0

11,530

12,922

43.1

6726

24,150

3.19

55.8

2.88

3.62

55.1

1.74

7.75

  1. BID, twice daily; CV%, coefficient of variation for geometric mean, CVb%, coefficient of variation for mean; GeoMean, geometric mean; na, not applicable; SSc, systemic sclerosis.