Table 1.
Summary of the PK results of amlodipine and losartan for the test drug (6.94 mg amlodipine besylate [5 mg as amlodipine]/50 mg losartan potassium) and the reference drug (5 mg amlodipine camsylate/50 mg losartan potassium)
| Variable | Test drug (n=45)
|
Reference drug (n=45)
|
GMR (90% CI)a |
|---|---|---|---|
| Mean ± SD (min–max) | Mean ± SD (min–max) | ||
| Amlodipine | |||
| Tmaxb (h) | 6.0 (4.0–8.0) | 6.0 (4.0–8.0) | |
| Cmax (μg/L) | 3.0±0.7 (1.7–4.5) | 3.1±0.6 (1.8–4.7) | 0.98 (0.94–1.01) |
| AUC0–t (h⋅μg/L) | 119.5±36.2 (57.3–226.4) | 123.7±37.9 (59.1–244.2) | 0.97 (0.93–1.01) |
| AUC0–∞ (h⋅μg/L) | 137.8±50.0 (72.9–294.7) | 141.1±52.7 (66.2–357.2) | |
| t1/2 (h) | 46.4±16.2 | 43.6±12.9 | |
| Losartan | |||
| Tmaxb (h) | 1.0 (0.5–3.0) | 1.0 (0.3–2.0) | |
| Cmax (μg/L) | 242.8±128.5 (36.9–641.9) | 249.6±107.6 (101.6–542.8) | 0.91 (0.81–1.02) |
| AUC0–t (h⋅μg/L) | 430.8±137.8 (200.4–859.5) | 409.7±133.0 (226.7–815.4) | 1.05 (0.98–1.12) |
| AUC0–∞ (h⋅μg/L) | 451.3±139.6 (217.7–882.4) | 432.3±136.8 (243.9–885.7) | |
| t1/2 (h) | 1.8±0.4 | 1.9±0.6 |
Notes: All values are presented as arithmetic mean ± SD.
a
GMR of the test drug to the reference drug.
b
Median (min–max).
Abbreviations: PK, pharmacokinetic; SD, standard deviation; GMR, geometric mean ratio; CI, confidence interval; Tmax, time to the peak concentration; Cmax, maximum plasma concentration; AUC0–t, area under the concentration curve from time zero to the last quantifiable time point; AUC0–∞, area under the concentration time curve from time 0 to infinity; t1/2, half-life.