Table 2.
Pharmacokinetic profile of teneligliptin in special populations
| Dose (mg/day) | n | Cmax (ng/mL)a | AUC∞ (ng·h/mL)a | t½ (h)a | Ratio to normal subjects (90% CI)b | |||
|---|---|---|---|---|---|---|---|---|
| C max | AUC∞ | t ½ | ||||||
| Renal impairment [34] | ||||||||
| Normal | 20 | 8 | 176.50 (38.42) | 1772.7 (657.3) | 26.1 (5.0) | |||
| Mild | 20 | 8 | 207.96 (53.31) | 2234.2 (278.6) | 27.7 (7.9) | 1.08 (0.86, 1.35) | 1.25 (1.01, 1.54) | 1.00 (0.76, 1.31) |
| Moderate | 20 | 8 | 203.63 (42.33) | 3090.3 (868.6) | 36.0 (11.0) | 1.12 (0.89, 1.40) | 1.68 (1.36, 2.07) | 1.36 (1.04, 1.79) |
| Severe | 20 | 8 | 191.63 (49.07) | 2833.3 (652.3) | 29.8 (11.0) | 1.04 (0.82, 1.32) | 1.49 (1.19, 1.86) | 1.02 (0.77, 1.37) |
| Renal impairment with ESRD [34] | ||||||||
| Normal | 20 | 8 | 195.75 (43.28) | 1843.1 (450.0) | 18.3 (5.7) | |||
| Pre-dialysis | 20 | 8 | 164.45 (78.85) | 2162.5 (488.1) | 22.7 (7.7) | 0.85 (0.64, 1.13) | 1.17 (0.94, 1.47) | 1.19 (0.89, 1.59) |
| Post-dialysis | 20 | 8 | 219.00 (118.91) | 2472.9 (599.7) | 23.6 (5.8) | 1.10 (0.82, 1.46) | 1.32 (1.06, 1.65) | 1.31 (0.98, 1.75) |
| Hepatic impairment [36] | ||||||||
| Normal | 20 | 8 | 185.88 (84.65) | 1548.8 (209.1) | 24.8 (6.4) | |||
| Mild | 20 | 8 | 229.25 (86.16) | 2207.9 (790.0) | 27.9 (7.1) | 1.25 (0.97, 1.62) | 1.46 (1.22, 1.74) | 1.22 (0.94, 1.57) |
| Moderate | 20 | 8 | 247.63 (112.95) | 2418.9 (505.8) | 30.9 (6.6) | 1.38 (1.07, 1.78) | 1.59 (1.33, 1.90) | 1.38 (1.07, 1.78) |
| Age (years) [31] | ||||||||
| ≥ 45 to < 65 | 20 | 12 | 143.6c | 1637.6c | 33.8c | |||
| ≥ 65 to ≤ 75 | 20 | 12 | 142.7c | 1502.8c | 32.1c | 1.01 (0.87, 1.16) | 1.09 (0.98, 1.22) | 1.05 (0.91, 1.22) |
AUC∞ area under the plasma concentration-time curve from time zero to infinity, Cmax maximal plasma concentration, ESRD end-stage renal disease, t½ elimination half-life, CI confidence interval
aMean (standard deviation)
bResults are reported as ratios of geometric means and the respective 90% CIs
cData are expressed as least square means as these were the only data available