Table 4.
Mean (standard deviation) PK parameters of nemonoxacin following single oral administration and once-daily oral administration for 10 days
| Dose (mg) group and time | Cmax (mg/L) | Tmax (h) | AUC24 (mg · h/L) | Ae(24h) (%) | CLR (L/h/kg) | Accumulation index |
|---|---|---|---|---|---|---|
| Guo et al23,c | ||||||
| 500 (n=12) | ||||||
| Day 1 | 6.46 (1.29) | 1.42 (0.90) | 43.93 (8.97) | 54.81 (11.61) | 0.11 (0.026) | NA |
| Day 10 | 7.02 (1.77) | 1.25 (0.45) | 46.92 (12.15) | 50.81 (16.07) | 0.10 (0.042) | 1.09 (0.05) |
| 750 (n=12) | ||||||
| Day 1 | 9.38 (2.70) | 1.92 (1.06) | 63.28 (10.52) | 56.24 (6.11) | 0.12 (0.024) | NA |
| Day 10 | 9.13 (1.55) | 1.46 (0.81) | 65.75 (9.06) | 65.38 (6.81) | 0.13 (0.024) | 1.10 (0.05) |
| Chung et al24,d | ||||||
| 500 (n=8) | ||||||
| Day 1 | 5.12 (1.04) | 1.00 (0.5–1.5)a | 31.60 (4.33) | 42.2 (13.1) | 6.92 (3.02)b | |
| Day 10 | 5.56 (1.39) | 1.31 (1.0–2.0)a | 38.60 (7.37) | 57.8 (9.6) | 7.85 (2.81)b | |
| 750 (n=8) | ||||||
| Day 1 | 5.75 (1.18) | 1.50 (1.0–2.0)a | 46.06 (9.28) | 47.1 (10.9) | 7.96 (2.32)b | |
| Day 10 | 6.82 (1.81) | 1.51 (1.0–2.0)a | 58.43 (14.32) | 41.8 (10.3) | 5.63 (1.74)b | |
| 1,000 (n=8) | ||||||
| Day 1 | 7.75 (2.15) | 2.00 (1.0–4.0)a | 59.65 (12.46) | 47.9 (8.7) | 7.48 (1.80)b | |
| Day 10 | 8.20 (2.03) | 2.07 (1.5–4.0)a | 74.84 (14.27) | 48.6 (13.7) | 6.87 (2.63)b | |
Notes: Copyright © 2012. Adapted with kind permission from Springer Science and Business Media. Guo B, Wu X, Zhang Y, et al. Safety and clinical pharmacokinetics of nemonoxacin, a novel non-fluorinated quinolone, in healthy Chinese volunteers following single and multiple oral doses. Clin Drug Investig. 2012;32(7):475–486.23 Copyright © 2010. Adapted with permission from American Society for Microbiology. Chung DT, Tsai CY, Chen SJ, et al. Multiple-dose safety, tolerability, and pharmacokinetics of oral nemonoxacin (TG-873870) in healthy volunteers. Antimicrob Agents Chemother. 2010;54(1):411–417. doi: 10.1128/AAC.00683-09.24
Tmax is represented by means (range)
CLR result is expressed as L/h
Chinese population
multiracial group, including African American (56.6%), Caucasian (28.3%), Hispanic (13%), and Asian (2.2%).
Abbreviations: PK, pharmacokinetic; Cmax, maximum concentration; Tmax, time that Cmax occurs; AUC, area under concentration–time curve; Ae(24h), percentage of the administered dose recovered in urine over 24 hours; CLR, renal clearance; NA, not available.