Table 1. Pharmacokinetic properties of nemonoxacin in Chinese healthy male volunteers after a single dose of 500 mg nemonoxacin alone or in combination with metal ion-containing agentsa.
Parameters | Treatmentsb in Study 1 |
Treatmentsc in Study 2 |
|||||
---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | |
AUC0–∞ (mg·h·L−1) | 40.7±5.4 | 17.1±15.4 | 7.9±2.2 | 37.2±5.1 | 44.4±6.8 | 16.1±3.0 | 36.5±8.2 |
AUC0–72 h (mg·h·L−1) | 40.5±5.3 | 16.9±15.3 | 7.8±2.2 | 36.9±5.0 | 44.0±6.7 | 15.9±2.9 | 36.2±8.1 |
Cmax (mg·L−1) | 5.54±0.91 | 2.62±2.67 | 1.23±0.42 | 5.72±0.86 | 6.63±1.65 | 2.85±1.39 | 5.68±2.05 |
Tmax (h) | 1.0 (0.67–2.0) | 1.0 (0.67–8.0) | 0.67 (0.67–1.0) | 1.0 (0.67–2.0) | 1.0 (0.67–2.5) | 0.67 (0.67–3.0) | 1.0 (0.67–2.0) |
T1/2 (h) | 12.5±1.9 | 13.0±1.8 | 11.0±2.2 | 12.2±3.1 | 13.0±1.5 | 12.9±2.3 | 12.4±2.1 |
CL/F (L·h−1) | 12.5±1.6 | 79.1±73.5 | 68.3±20.7 | 13.7±2.2 | 11.5±1.7 | 32.0±5.7 | 14.3±3.1 |
Vz/F (L) | 226±48 | 1390±1150 | 1050±245 | 242±72 | 218±48 | 598±149 | 256±67 |
Ae (%) | 65.3±19.3 | 27.6±23.7 | 15.5±5.9 | 58.5±12.8 | 72.2±15.7 | 29.1±11.1 | 58.9±15.8 |
CLr (L·h−1) | 8.25±2.82 | 9.50±2.58 | 10.10±2.60 | 8.06±2.02 | 8.46±2.51 | 9.09±2.80 | 8.38±2.48 |
a Data are presented as the arithmetic mean±SD except for Tmax, which is presented as the median (range).
b A, Nemonoxacin was administered alone; B, nemonoxacin was administered 4 h after an Al3+- and Mg2+-containing antacid; C, nemonoxacin was administered at the same time as the Al3+- and Mg2+-containing antacids; D, nemonoxacin was administered 2 h before the Al3+- and Mg2+-containing antacid;
c E, nemonoxacin was administered alone; F, nemonoxacin was administered at the same time as ferrous sulfate; G, nemonoxacin was administered at the same time as calcium carbonate.