Product A
Parameters Arithmetic Mean
mean [SD]
Range
AUC0-∞ (ng*min/mL) 1719.93 [918.47] 761.49-3167.70
Cmax (ng/mL) 17.2 [9.3] 7.4-37.4
Tmax (min) 42.5 [24.9] 20.0-90.0
T1/2(min) 54.0 [9.6] 45.3-75.6
Ka (min-1) 0.0311 [0.0188] 0.0127-0.0656
MRT (min) 57.2 [18.2] 32.0-86.3
                                                  Product B
AUC0-∞ (ng*min/mL) 1179.23 [776.80] 232.84-2579.90
Cmax (ng/mL) 12.4 [6.6] 3.6-22.9
Tmax (min) 37.5 [11.7] 20.0-60.0
T1/2(min) 51.9 [13.4] 34.0-69.1
Ka (min-1) 0.0438 [0.0560] 0.0176-0.1820
MRT (min) 51.6  [13.8] 33.4-72.9
                                             Ratio A/B
Variable mean [SD] Range
AUC0-∞ (ng*min/mL) 1.86 [1.17] 0.87-4.07
Cmax (ng/mL) 1.5 [0.5] 0.9-2.5
Table 3: Pharmacokinetic parameters of Melatonin in emulsion spray Product A and Melatonin tablet Product B (8 subjects; dose 5 mg).
Goto home»