Table 2.
Subject characteristics at baseline in the bioequivalence and pharmacokinetic studies
| Bioequivalence, PP | Pharmacokinetics | ||||||
|---|---|---|---|---|---|---|---|
| Cohort 1 | Cohort 2 | ||||||
| Lubiprostone sprinkle (n = 234) | Lubiprostone capsule (n = 113) | PBO (n = 126) | Capsule → sprinkle (n = 18) | Sprinkle → capsule (n = 17) | Sprinkle fed → fasted (n = 7) | Sprinkle fasted → fed (n = 7) | |
| Sex, n (%) | |||||||
| Female | 202 (86.3) | 92 (81.4) | 105 (83.3) | 9 (50.0) | 10 (58.8) | 4 (57.1) | 4 (57.1) |
| Age, years | |||||||
| Mean | 47.4 | 48.8 | 46.7 | 41.5 | 35.7 | 36.6 | 34.6 |
| Min, max | 18, 84 | 21, 84 | 21, 80 | 25, 55 | 22, 50 | 23, 46 | 25, 47 |
| ≥ 65 years, n (%) | 21 (9.0) | 13 (11.5) | 8 (6.3) | ||||
| Race, n (%) | |||||||
| White | 120 (51.3) | 59 (52.2) | 71 (56.3) | 15 (83.3) | 14 (82.4) | 3 (42.9) | 4 (57.1) |
| Black | 99 (42.3) | 48 (42.5) | 50 (39.7) | 3 (16.7) | 3 (17.6) | 4 (57.1) | 2 (28.6) |
| Ethnicity, n (%) | |||||||
| Hispanic | 64 (27.4) | 33 (29.2) | 31 (24.6) | 12 (66.7) | 9 (52.9) | 2 (28.6) | 3 (42.9) |
| Not Hispanic | 170 (72.6) | 80 (70.8) | 95 (75.4) | 6 (33.3) | 8 (47.1) | 5 (71.4) | 4 (57.1) |
| Weight, kg | |||||||
| Mean (SD) | 83.2 (19.9) | 83.7 (20.6) | 85.0 (24.8) | 73.5 (10.5) | 75.3 (11.1) | 72.8 (8.1) | 65.2 (9.6) |
| BMI, kg/m2 | |||||||
| Mean (SD) | 30.6 (6.6) | 30.4 (7.2) | 30.9 (7.8) | 26.0 (2.5) | 25.6 (3.8) | 26.5 (2.8) | 24.1 (2.5) |
| SBM count | |||||||
| Mean (SD) | 1.37 (0.69) | 1.35 (0.72) | 1.38 (0.69) | ||||
| Stool consistency | |||||||
| Mean (SD) | 2.39 (1.21) | 2.28 (1.05) | 2.47 (1.12) | ||||
| Straining | |||||||
| Mean (SD) | 2.31 (0.91) | 2.40 (0.89) | 2.39 (0.74) | ||||
BMI body mass index, PBO placebo, SBM spontaneous bowel movement, SD standard deviation