Table 1. Pharmacokinetic parameters of TP alone and the co-administration of ATFX.
Parameters | TP alone | TP plus ATFX | Point estimate (90% CI) | |
---|---|---|---|---|
1st day | AUC0–24 (μg·h/mL) | 50.00±14.49 | 51.77±10.27 | 106.6% (94.4%–120.4%) |
Cmax (μg /mL) | 3.00±0.91 | 3.23±1.30 | 106.4% (88.7%–124.6%) | |
Tmax (h) | 4.8±2.8 | 6.2±1.8 | / | |
Cl (L/h) | 4.45±1.74 | 4.01±0.81 | 95.7% (86.3%–105.2%) | |
Ae(0–24) | / | |||
1-MX (mg) | 3.82±3.22 | 5.19±2.67 | / | |
3-MX (mg) | 6.13±2.12 | 5.36±1.39 | / | |
1,3-DMU (mg) | 5.93±3.15 | 6.60±5.21 | / | |
TP (mg) | 21.46±5.83 | 20.21±4.33 | / | |
5th day | AUC0–12 (μg·h/mL) | 92.64±27.08 | 117.72±27.77b | 129.4% (113.7%–147.3%) |
AUC0–24 (μg·h/mL) | 152.95±43.06 | 200.04±525b | 132.7% (118.7%–148.5%) | |
Cmax (μg/mL) | 9.32±2.70 | 12.02±2.41b | 132.1% (114.0%–153.1%) | |
Tmax (h) | 3.0±1.2 | 3.3±0.9 | / | |
t1/2 (h) | 17.93±5.08 | 18.66±5.04 | / | |
Cl (L/h) | 2.36±0.81 | 1.78±0.39b | 77.2% (67.8%–87.9%) | |
Clr (L/h) | 0.34±0.07 | 0.32±0.08 | 93.6% (78.9%–111.3%) | |
Clnr (L/h) | 2.03±0.78 | 1.46±0.37c | 74.4% (65.7%–84.3%) | |
Ae(0–24) | / | |||
1-MX (mg) | 25.49±21.17 | 9.76±5.07b | / | |
3-MX (mg) | 28.75±13.38 | 19.44±5.06b | / | |
1,3-DMU (mg) | 39.24±29.70 | 20.77±15.60b | / | |
TP (mg) | 53.13±17.23 | 66.75±15.69b | / |
For TP, on d 1 and 5, 200 mg of TP was given to subjects as a single morning dose. On d 2 to 4, 400 mg of TP was given to subjects twice daily (morning dose and evening dose). For ATFX, on d 1, 400 mg was given to subjects as a single morning dose, and on d 2 to 5, 200 mg of ATFX was given to subjects once daily (morning dose). The results are expressed as the mean±SD (n=12).
bP<0.05,
cP<0.01 vs TP alone.