Parameter (Units) |
Amlodipine Capsule (with Water, n=35) |
Amlodipine ODT (Without Water, n=35) |
Amlodipine ODT (With Water, n=33) |
AUC∞ (ng*hr/mL) |
433.8 (155.7) |
424.1 (123.4) |
442.8 (119.3) |
Ratio (90% CI)* |
|
97.89
(92.75, 103.32) |
102.74
(97.27, 108.51) |
AUClast (ng*hr/mL) |
372.0 (123.8) |
368.3 (102.6) |
385.0 (97.7) |
Ratio (90% CI)* |
|
100.42
(92.81, 108.66) |
105.55
(97.44, 114.33) |
Cmax (ng/mL) |
6.3 (1.5) |
5.7 (1.4) |
5.9 (1.5) |
Ratio (90% CI)* |
|
89.94
(86.32, 93.71) |
94.09
(90.26, 98.08) |
Tmax (h) |
6.0 (2.0–12.0) |
8.0 (2.0–16.0) |
6.0 (4.0–16.0) |
t½ (h) |
53.9 (15.5) |
55.7 (11.0) |
54.5 (9.9) |
Arithmetic (standard deviation) for all except median (range) for Tmax.
*Ratio of adjusted geometric mean (90% CI) for Test (amlodipine ODT with or
without water) versus Reference (amlodipine capsule with water) treatment. |