Arzneimittelforschung 2008; 58(01): 42-47
DOI: 10.1055/s-0031-1296465
Antibiotics · Antimycotics · Antiviral Drugs · Chemotherapeutics · Cytostatics
Editio Cantor Verlag Aulendorf (Germany)

Bioequivalence Study of Two Oral Formulations of Cefadroxil in Healthy Volunteers

Kazue Eunice Kano
Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brazil
Valentina Porta
Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brazil
Eunice Emiko Mori Koono
Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brazil
Simone Grigoleto Schramm
Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brazil
Cristina Helena dos Reis Serra
Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brazil
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15. Dezember 2011 (online)


Two different cefadroxil (CAS 50370-12-2) formulations were evaluated for their relative bioavailability in 24 healthy volunteers who received a single 500 mg oral dose of each preparation. An open, randomized clinical trial designed as a two-period crossover study with a 7-day washout period between doses was employed. Plasma samples for assessments of their cefadroxil concentration by HPLC-UV were obtained over 8 h after administration. Values of 48.94 ± 10.18 µg . h/ml for test, and 48.51 ± 9.02 µg . h/ml for the reference preparation AUC0-t demonstrate a nearly identical extend of drug absorption. Maximum plasma concentration Cmax of 16.04 ± 4.94 µg/ml and 16.01 ± 4.02 µg/ml achieved for the test and reference preparations did not differ significantly. The parametric 90% confidence intervals (CI) of the mean of the difference (test-reference) between log-transformed values of the two formulations were 96.80% to 104.51% and 92.01% to 107.00% for AUC0-t and Cmax, respectively. Since for both AUC0-t or Cmax the 90% CI values are within the interval proposed by the Food and Drug Administration, the test product is bioequivalent to the reference product for both the rate and extent of absorption after single dose administration.

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