Three-ways crossover bioequivalence study of cephalexin in healthy Malay volunteers

Context: Although the general pharmacokinetics of cephalexin is quite established up-to-date, however, no population-based study on Cephalexin pharmacokinetics profile in Malay population has been reported yet in the literature.

Objective: The objective of this study was to investigate the pharmacokinetics and to compare the bioavailability of three cephalexin products, Ospexin® versus MPI Cephalexin® tablet and MPI Cephalexin® capsule, in healthy Malay ethnic male volunteers in Malaysia.

Material and method: A single dose, randomized, fasting, three-period, three-treatment, three-sequence crossover, open label bioequivalence study was conducted in 24 healthy Malay adult male volunteers, with 1 week washout period. The drug concentration in the sample was analyzed using high performance liquid chromatography.

Result: The mean (SD) pharmacokinetic parameter results of Ospexin® were C_max, 17.39 (4.15) μg/mL; AUC_0–6, 28.90 (5.70) µg/mL?*?h; AUC_0–∞, 30.07 (5.94) µg/mL?*?h; while, those of MPI Cephalexin® tablet were C_max, 18.29 (3.01) μg/mL; AUC_0–6, 30.02 (4.80) µg/mL?*?h; AUC0_0–∞, 31.33 (5.18) µg/mL?*?h and MPI Cephalexin® capsule were C_max, 18.25 (3.92) μg/mL; AUC_0–6, 30.04 (5.13) µg/mL?*?h; AUC_0–∞, 31.22 (5.29) µg/mL?*?h.

Conclusion: The 90% confidence intervals for the logarithmic transformed C_max, AUC_0–6 and AUC_0–∞, of Ospexin® versus MPI Cephalexin® tablet and Ospexin® versus MPI Cephalexin® capsule were between 0.80 and 1.25. Both C_max and AUC met the predetermined criteria for assuming bioequivalence. The pharmacokinetic profile of cephalexin in Malay population does not vary much from other world population.