Parameter (Units) |
Amlodipine Tablet (With Water, n=35) |
Amlodipine ODT (Without Water, n=36) |
Amlodipine ODT (With Water, n=35) |
AUC∞ (ng*hr/mL) |
498.6 (133.0) |
481.4 (162.3) |
495.9 (149.7) |
Ratio (90% CI)* |
|
95.88
(90.47, 101.61) |
98.79
(93.21, 104.70) |
AUClast (ng*hr/mL) |
420.3 (97.1) |
404.5 (111.3) |
423.0 (111.1) |
Ratio (90% CI)* |
|
96.10
(90.98, 101.52) |
100.09
(94.74, 105.74) |
Cmax (ng/mL) |
6.7 (1.2) |
6.4 (1.3) |
6.8 (1.6) |
Ratio (90% CI)* |
|
95.14
(90.44, 100.08) |
100.23
(95.27, 105.45) |
Tmax (h) |
8.0 (3.0–16.0) |
8.0 (6.0–14.0) |
8.0 (2.0–16.0) |
t½ (h) |
61.5 (18.7) |
57.6 (19.2) |
58.2 (11.6) |
Arithmetic mean (standard deviation) for all except median (range) for Tmax.
*Ratio of adjusted geometric means (90% CI) for Test (amlodipine ODT with or
without water) versus Reference (amlodipine tablet with water) treatment. |