Potential pharmacokinetic interactions in fixed-dose combinations of perindopril/indapamide/amlodipine compared with perindopril/indapamide and amlodipine in healthy Chinese volunteers

S05590 is a fixed-dose combination of perindopril tert-butylamine 4 mg/indapamide 1.25 mg, and S06593 arginine 5 mg/amlodipine mg. The purpose this study was to determine whether pharmacokinetic interactions exist among the components S06593, compared with amlodipine as reference drugs, in healthy Chinese male volunteers after single oral administration under fasting conditions. A single-center, open-label, randomized, three-period, six-way crossover conducted. total 42 participants were enrolled randomized receive plus amlodipine, or S06593. doses 3.34 mg both calculated free acid. Blood samples collected each treatment period plasma concentrations perindopril, indapamide well perindoprilat, main metabolite perindopril. 39 completed study. 90% confidence intervals geometric mean ratios C max , AUC 0-t 0-∞ for all within 80.00–125.00%, thus indicating that pharmacokinetically equivalent. During study, only one serious emergent adverse event reported, which deemed not be associated drug. No treatment-associated events observed.