| Abstract | dc.description.abstract | Changes in bioavailability of
anticonvulsant drugs such as topiramate may
cause loss of or worsened seizure control.
Thus, the purpose of this study was to evaluate,
in a double-blind crossover design, the
bioavailability between two oral formulations
of topiramate in healthy volunteers after
a single dose. The protocol, approved by the
Institutional Committee of Ethics, consisted
of administration of 1 tablet of 100 mg of topiramate
of each formulation (Toprel™ and
Topamax™), to 20 healthy volunteers after a
12 h overnight fast, using an open, two-period,
randomized, crossover and double-blind design.
Thus, the plasma concentrations (Cp)
of topiramate weremeasured at predetermined
intervals of time, from 0 to 24 h, using a
validated UPLC-MS/MS method. Based on
plasma concentration-time profiles we obtained
the following pharmacokinetic parameters:
AUC0– 63,418.31 ± 22,141.69 and
67,094.70 ± 22,487.2 ngh/ml; AUC0–24:
30,421.02 ± 9,964.0 and 30,489.35 ± 9,407.17,
ng h/ml; tmax: 2.77 ± 1.76 and 1.95 ± 1.89 h;
Cmax: 2,143.33 ± 724.26 and 2,262.51 ±
751.12 ng/ml, for A (Toprel™) and B (Topamax
™), respectively. All these differences
were not statically significant with 90% confidence
interval. The test of bioequivalence
showed that Cmax, AUC0–24 and AUC0–
parameters are found within the range of
0.8 – 1.25 recommended by the FDA with a
probability of bioequivalence of 100%. In accordance
with these results, we can conclude
that Toprel™ 100 mg, A (Test), is a bioequivalent
generic and interchangeable with Topamax
™ 100 mg, B (Reference). | en_US |
