TABLE 2.
Noncompartmental pharmacokinetic parameters of 17-OHPC during pharmacokinetic studies 1 and 2
| Variable | AUCt1t2 (ng/mL/d) | Ctrough (ng/mL) | CMAX (ng/mL) | TMAX (d) | t1/12 (d) | Vd/F (*103) (L) | Cl/F (*103) (L/d) | |
|---|---|---|---|---|---|---|---|---|
| Pharmacokinetic study | ||||||||
| 1 (n = 47) | 107 (81.1–144.2) | 12.4 (10.0–18.0) | 21.0 (15.8–27.4) | 1.0 (1.0–3.0) | ||||
| 2 (n = 47) | 125 (96.5–165.1) | 14.6 (11.5–21.0) | 24.3 (18.0–31.1) | 1.0 (1.0–3.5) | ||||
| P valuea | .002 | .011 | .007 | .51 | ||||
| Extended pharmacokinetic study 2b (n = 18) | 120 (92.0–168.0) | 14.0 (12.8–19.8) | 23.8 (17.3–29.0) | 1.0 (1.0–4.0) | 16.2 (10.6–21.0) | 56 (25.2–69.6) | 2.1 (1.5–2.7) | |
Data are presented as median pharmacokinetic parameter and interquartile range (IQR; Q1–Q3, where Q1 is the 25th percentile and Q3 is the 75th percentile) that were observed for 47 subjects with singleton pregnancies who had sampling done daily for 7 days.
AUCt1t2, area under the concentration vs time curve; Cl/F, clearance/bioavailability; CMAX, maximum concentration during the dosing interval; Ctrough, the minimum concentration at time zero, just before the next injection; 17-OHPC, 17-hydroxyprogesterone caproate; t1/2, apparent half-life; TMAX, time to maximum concentration; Vd/F, apparent volume of distribution/bioavailability.
Wilcoxon signed rank test–generated probability values (P < .05) indicate significant difference between pharmacokinetic studies 1 and 2;
Extended pharmacokinetic study, median pharmacokinetic parameters and interquartile range that were observed for 18 subjects with singleton pregnancies who had sampling done for 28 days after the last injection.
Caritis. Pharmacology and placental transport of 17-OHPC. Am J Obstet Gynecol 2012.