Bioequivalence Study of 100 mg Cilostazol Tablets in Healthy Thai Adult Volunteers

This study was conducted at the Siriraj Clinical Research Center, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. Each volunteer was initially treated according to either the Test-Reference (TR) or the Reference-Test (RT) sequence, after which each subject was switched to the other study sequence after a two-week washout period. Pharmacokinetic analysis was performed using log-transformed ratios (test/reference) for Cmax, AUC0-tlast, AUC0-∞, Tmax, t1/2, and λZ for both cilostazol and 3,4-dehydro-cilostazol (its active metabolite) with 90% confidence interval. Physical examination, clinical laboratory data, vital signs, and adverse events (AEs) were assessed in all patients.FindingsA total of 28 volunteers were included in the final analysis. The ratios of the geometric mean and the 90% confidence interval compared test to reference of cilostazol formulations were 101.86% (91.88%-112.92%), 107.78% (99.67%-116.56%), and 110.46% (102.68%-118.82%) for Cmax, AUC0-tlast, and AUC0-∞, respectively. The ratios of the geometric mean and the 90% confidence interval compared test to reference of 3,4-dehydro-cilostazol were 106.72% (95.31%-119.50%), 110.54% (101.92%-119.89%), and 107.37% (96.74%-119.16%) for Cmax, AUC0-tlast, and AUC0-∞, respectively. No significant difference was observed between formulations for Tmax. The most common adverse event was headache (51.85%), with no significant difference in incidence between the test and reference groups....
Source: Current Therapeutic Research - Category: Drugs & Pharmacology Source Type: research