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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.