Table 1.
Demographic profile of enrolled subjects.
| Single ascending-dose study | Multiple ascending-dose study | Food-effect study | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 25 mg (n = 4) | 200 mg (n = 6) | 400 mg (n = 6) | 800 mg (n = 6) | 1200 mg (n = 6) | Placebo (n = 10) | 200 mg (n = 9) | 400 mg (n = 9) | 600 mg (n = 9) | Placebo (n = 9) | Group A* (n = 4) | Group B* (n = 4) | Group C* (n = 4) | |
| Age, year | 27.3 (7.18) | 31.3 (4.89) | 29.7 (5.65) | 27.2 (5.12) | 31.2 (7.73) | 29.2 (6.80) | 28.0 (3.46) | 29.2 (6.34) | 29.0 (6.06) | 30.3 (6.73) | 26.5 (4.43) | 27.8 (3.83) | 29.0 (7.26) |
| Gender | |||||||||||||
| Male | 4 (100) | 6 (100) | 6 (100) | 5 (83.3) | 6 (100) | 8 (80.0) | 8 (88.9) | 9 (100) | 9 (100) | 8 (88.9) | 3 (75.0) | 4 (100) | 4 (100) |
| Female | 0 | 0 | 0 | 1 (16.7) | 0 | 2 (20.0) | 1 (11.1) | 0 | 0 | 1 (11.1) | 1 (25.0) | 0 | 0 |
| Height, cm | 171.0 (6.48) | 170.6 (4.33) | 168.1 (2.69) | 165.2 (9.07) | 167.4 (5.34) | 166.7 (8.62) | 168.8 (7.55) | 167.0 (5.08) | 165.5 (3.95) | 164.9 (3.92) | 163.4 (4.79) | 169.5 (4.98) | 166.9 (4.25) |
| Weight, kg | 65.6 (9.79) | 60.3 (5.50) | 62.7 (4.18) | 65.0 (11.38) | 63.4 (8.52) | 63.8 (9.61) | 64.3 (6.42) | 63.9 (6.96) | 60.9 (5.55) | 60.5 (5.70) | 57.6 (6.21) | 64.6 (7.11) | 63.0 (5.42) |
| BMI, kg/m2 | 22.3 (1.73) | 20.7 (1.07) | 22.2 (1.16) | 23.7 (2.45) | 22.5 (1.77) | 22.8 (1.51) | 22.6 (1.89) | 22.9 (1.75) | 22.2 (1.61) | 22.2 (2.04) | 21.6 (1.36) | 22.4 (1.12) | 22.6 (1.71) |
BMI body mass index.
Note: Data are expressed as mean (SD), except for gender, which is shown as n (%).
*Group A, B, and C experienced three treatment periods, respectively.
Group A: fasting→standard meal→high-fat meal.
Group B: high-fat meal→fasting→standard meal.
Group C: standard meal→high-fat meal→fasting.