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.
Table 1: Summary of pharmacokinetic parameters in the pivotal bioequivalence study of amlodipine ODT versus amlodipine tablets.
Goto home»