Resumen

COHEN SABBAN, Hugo  y  GONZALEZ YIBIRIN, María. Comparison of the bioavailability of a test product containing Sultamicillin tablets of 375 mg immediate release Laboratorios GENVEN (LETI, SAV) against sultamicillin reference (Unasyn ^®) 375 mg tablets of PFIZER, after single dose administration in healthy volunteers. AVFT [online]. 2012, vol.31, n.1, pp.6-10. ISSN 0798-0264.

Objective: Evaluated the comparative bioavailability of two formulations of immediate release 375 mg Sultamicillin after a single administration in the same group of healthy volunteers. Methods: The study was conducted in 12 healthy volunteers of both sexes. The volunteers were assigned according to the randomization scheme and two periods, a single oral dose of one tablet of a formulation containing 375 mg of Sultamicillin Genven (Leti, S.A.V.) Laboratories, or the reference product Unasyn^®, Pfizer Laboratories. The administration was carried out in fast of 10 hours and continued for two hours after administering the drug. Between the two periods was a washout period of three days. Volunteers who received the test product in the first period will receive the reference product and vice versa. During each period of twelve samples were obtained from blood: pre-dose (time zero) 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 minutes. Results: For ampicillin pharmacokinetic parameters were Cmax test formulation 2.488.52+/-730.65 ng/mL and reference formulation 2.392,78+/-931.12 ng/mL; for AUC_0-6 were 169.495,82+/-57.506,34 ng/mL/h for the test formulation and 178.688,42+/-85.534,02 ng/mL/h for the reference formulation, for the AUC_0-∞ the resulting values were 171.230+/- 57.601,31 ng/mL/h for the test formulation and 179.553,73+/- 85.966 ng/mL/h for the reference formulation. For sulbactam pharmacokinetic parameters were: Cmax: test 2.176,66+/-711.57 ng/mL and reference 2.097,70+/- 486.17 ng/mL; the AUC_0-6 were 175.924,62+/-45.652,94 ng/ mL/h for the test formulation and 186.342.94+/-47.001,80 ng/mL/h for the reference formulation, for the AUC_0-∞ the resulting values were 176.900.54+/-45.843,65 ng/mL/h to formulation test and 187.399,88+/-47.487,22 ng/mL/h for the reference formulation. The pharmacokinetic parameters for Ampicillin and Sulbactam, Cmax, AUC_0-6 and AUC_0-∞ and log transformed confidence intervals 90% were among the accepted margins for the products are considered bioequivalent. Conclusions: Both products are bioequivalent and therefore interchangeable.

Palabras clave : Ampicillin; sulbactam; sultamicillin; bioequivalence.