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Table 1 Mean (SD) pharmacokinetic parameters after single dosing and at steady state for OROS hydromorphone ER and IR hydromorphone in healthy subjects

From: Complementary pharmacokinetic measures to further define the profile of once-daily OROS hydromorphone ER during single-dose and steady-state dosing

Parameter, mean (SD)

OROS hydromorphone ER

IR Hydromorphone, fasted

Fed

Fasted

Study A

No. of subjects

29

30

30

AUC last , ng•h/mL

45.9 (11.2)

46.9 (13.8)

43.9 (10.4)

AUC 0-24 , ng•h/mL

25.6 (6.5)

25.7 (6.6)

30 (7.6)

C max , ng/mL

1.8 (0.5)

1.9 (0.5)

3.6 (1.5)

t max , ha

16 (5.9–24.2)

17.9 (6.0–24.2)

18.5 (18.5–20.0)

t ½,λ , h

14.4 (4.1)

14.4 (6.0)

12.7 (3.4)

Time ≥50% C max , h

23.6 (8.0)

21.6 (6.7)

5.9 (4.1)

Study B

No. of subjects

29

30

AUC 0-24 , ng•h/mL

57.6 (16.3)

54.8 (14.8)

C maxss , ng/mL

3.54 (0.96)

5.28 (1.37)

C minss , ng/mL

2.15 (0.87)

1.47 (0.42)

t maxss , ha

11.9 (5.9–24.2)

7.0 (0.5–18.8)

Peak-to-trough fluctuation (flux), %

60.5 (41.1)

172 (57.6)

Time ≥50% C max , h

20.5 (4.1)

7.5 (4.8)

  1. AUC 0-24, area under the concentration versus time curve from time 0 to 24 hours postdose; AUC last , area under the concentration versus time curve from time 0 to the last quantifiable concentration; C max , maximum plasma concentration; C maxss , maximum plasma concentration at steady state; C minss , trough plasma concentration at steady state; ER, extended-release; IR, immediate-release; t ½,λ , apparent elimination half-life; t max , time to maximum plasma concentration; t maxss , time to maximum plasma concentration at steady state.
  2. a. Median (range) reported for t max .