Bioequivalence study of cilostazol 100-mg orally disintegrated tablets and cilostazol 100-mg conventional tablets in healthy adult male subjects

Cilostazol orally disintegrated tablets (ODT) are a newly developed formulation for easier swallowing by patients with swallowing disorders that make it difficult for them to take tablets with water. The bioequivalence of one cilostazol 100-mg ODT ingested with or without water and one cilostazol 100-mg conventional tablet ingested with water was evaluated in healthy adult male subjects in an open-label, randomized, 2-formulation, 2-treatment, 3-period crossover study. Thirty six subjects were enrolled, and 32 subjects completed the study. The differences in the mean log-transformed AUC _60h and C _max values between the ODT without water and the conventional tablet (ODT without water-conventional tablet, point estimates) were both log (0.94), with respective 90% confidence intervals of log (0.88) to log (1.00) and log (0.87) to log (1.02). The differences in the mean log-transformed AUC _60h and C _max values between the ODT with water and the conventional tablet (ODT with water-conventional tablet, point estimates) were both log (0.98), with respective 90% confidence intervals of log (0.92) to log (1.04) and log (0.91) to log (1.06). All values were within the range of the equivalence judgment criteria of log (0.8) to log (1.25) specified in the guideline for bioequivalence studies. Based on the above results, one cilostazol 100-mg ODT, when administered either with or without water, was judged to be bioequivalent to one cilostazol 100-mg conventional tablet. All adverse events observed in all groups were mild or moderate in severity and were resolved. Deaths or other serious adverse events or clinically significant adverse events did not occur.