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.
Table 2: Summary of pharmacokinetic parameters in the pivotal bioequivalence study of amlodipine ODT versus amlodipine capsules.
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