OBJECTIVE To study the
bioequivalence of
Metformin Hydrochloride', 1, 1594791)"; href="/tags/metformin-hydrochloride/">metformin hydrochloride tablets in healthy volunteers.METHODS A single oral dose(1 000 mg) and multiple oral doses(1 000 mg·d~(-1)×7 d) of reference or test metformin
Hydrochloride preparations were given to 20 healthy male volunteers according to an open randomized crossover study.The plasma concentrations of metformin hydrochloride were determined by
RP-HPLC method.The
pharmacokinetic parameters and bioavailability of test preparation were compared with reference preparation.RESULTS The main pharmacokinetic parameters of the test preparation and the reference preparation were as follows,single dose(SD): ρ_(max)(2.329±0.486) and(2.308±0.502) mg·L~(-1);t_(max)(3.700±0.571) and(3.600±0.940)h;t_(1/2)(7.484±2.612) and(7.724±2.799)h;AUC_(0～t)(13.387±3.394) and(13.589±2.917) mg·h·L~(-1);AUC_(0～∞)(18.575±3.841) and(19.069±3.792) mg·h·L~(-1).The relative bioavailability of the test to reference preparation was(98.10±8.90)%.Multiple doses(MD): ρ_(max)(1.876±0.545) and(2.111±0.630) mg·L~(-1);ρ_(min)(0.212±0.047) and(0.227±0.054)mg·L~(-1);t_(max)(4.100±0.912) and(3.750±0.716)h;t_(1/2)((11.477±3.851))and(13.529±4.067) h;AUC_(ss)(15.137±2.749) and(15.855±3.322) mg·h·L~(-1);ρ_(av)(0.631±0.114) and((0.661±0.138)) mg·L~(-1);DF(2.609±0.644)% and(2.812±0.645)%,respectively.The relative bioavailability of test to reference preparation was(98.00±22.7)%.CONCLUSION The results of statistic analysis show that the reference preparation and the test preparation are bioequivalent.
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