Table 2.
Pharmacokinetic parameters (means ± standard deviations [SDs]) following a single oral dose of saroglitazar 1 mg in healthy subjects under fasting and fed conditions
| Sex | N | t max (h) | C max (ng/mL) | AUClast (ng·h/mL) | AUC∞ (ng·h/mL) | t ½β (h) |
|---|---|---|---|---|---|---|
| Male | ||||||
| Fasting | 6 | 1.00 ± 0.52 | 93.16 ± 42.12 | 249.19 ± 104.58 | 253.82 ± 103.97 | 5.39 ± 1.33 |
| Feda | 5 | 2.00b ± 0.00 | 49.42b ± 15.95 | 198.05 ± 36.86 | 202.44 ± 34.99 | 11.78b ± 4.77 |
| Female | ||||||
| Fastinga | 5 | 0.90 ± 0.14 | 96.95 ± 23.56 | 287.97 ± 101.10 | 297.36 ± 100.12 | 2.86c ± 1.08 |
| Fed | 6 | 2.38 ± 1.79 | 84.06 ± 40.74 | 275.75b ± 123.13 | 288.09b ± 128.72 | 3.77c ± 1.79 |
AUC area under the plasma concentration–time curve, AUC last AUC from time zero to the time of the last measurable concentration, AUC ∞ AUC from time zero to infinity, C max maximum plasma concentration, t ½β elimination or terminal half-life, t max time to reach C max
aOne male subject did not report during the fed period of the study, and one female subject withdrew her consent during the fasting period of the study. The means of all available data (n = 5 or 6, as available) are shown in the table
bSignificant (p < 0.05) using a paired t test for fed versus fasting for n = 5 subjects: for 5 fasting male subjects, the t max, Cmax and t ½β (mean ± SD) values were 1.00 ± 0.59 h, 99.77 ± 43.47 ng/mL and 5.00 ± 1.03 h, respectively. For 5 fed female subjects, the AUClast and AUC∞ (mean ± SD) values were 242.31 ± 102.79 ng·h/mL and 252.08 ± 104.82 ng·h/mL
cSignificant (p < 0.05) using unpaired t test for males as compared with females