Parameter

Test product

Reference Product

Cmax (µg/mL)

2.226 (0.355)

2.314 (0.414)

Tmax (h)

1.380 (1.060)

0.933 (0.729)

ke (h)

0.020 (0.004)

0.021 (0.005)

t1/2 (h)

36.261 (6.801)

35.694 (9.476)

AUC0-120 (µg/mL)× h

69.277 (13.432)

70.148 (10.824)

AUC0-∞ (µg/mL)× h

77.532 (15.255)

78.524 (16.000)

Table 2: Pharmacokinetic parameters (mean (SD)) of lamotrigine after a single 100 mg oral dose of the two products in healthy Colombian volunteers (n=12).
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