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

ABSTRACT

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 Cmax, 17.39 (4.15) µg/mL; AUC0-6, 28.90 (5.70) µg/mL * h; AUC0-∞, 30.07 (5.94) µg/mL * h; while, those of MPI Cephalexin® tablet were Cmax, 18.29 (3.01) µg/mL; AUC0-6, 30.02 (4.80) µg/mL * h; AUC00-∞, 31.33 (5.18) µg/mL * h and MPI Cephalexin® capsule were Cmax, 18.25 (3.92) µg/mL; AUC0-6, 30.04 (5.13) µg/mL * h; AUC0-∞, 31.22 (5.29) µg/mL * h. CONCLUSION: The 90% confidence intervals for the logarithmic transformed Cmax, AUC0-6 and AUC0-∞, of Ospexin® versus MPI Cephalexin® tablet and Ospexin® versus MPI Cephalexin® capsule were between 0.80 and 1.25. Both Cmax 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.