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Aim This study assessed the linearity of pharmacokinetics (PK) oftrimetazidine (TMZ) modified-release tablets (indicated in adults as an add-ontherapy for stable angina pectoris) and measured its renal elimination, safety,and tolerability in healthy subjects.  Methods This was a randomized, open-label, single-ascending dose study inhealthy subjects. Subjects were administered with a single dose of 35, 70, or105 mg TMZ-modified release tablets (six subjects each). Pharmacokineticevaluations and safety analysis were performed before the first dose and till48 h post-first dose.  Results Following administration of 35, 70, and 105 mgTMZ-modified release; the Cmax (mean±SD) was 79.32(±23.08), 153.17 (±23.08), and 199.67 (±23.08)ng/mL, the Tmax was 5.42 (±0.49), 4.51(±1.27), and 4.57 (±0.96) h, t1/2 was 7.75(±1.62), 6.40 (±1.23), and 6.50 (±1.18) h,AUC(0-inf) was 1116.89 (±378.35), 1838.39(±284.50), and 2504.84 (±348.35) ng.h/mL, CLRwas 13.70 (±2.24), 14.80 (±5.91), and 19.58 (±6.24)L·h−1 and CL/F was 33.69 (±8.51),38.85 (±6.15), and 42.74 (±7.10)L·h−1, respectively. Slope estimates forAUC(0-inf), AUC(0-t), and Cmax were lessthan 1. Corresponding 95% CI of the slope for the AUC parametersexcluded 1, indicating that the deviation from dose-proportionality wasstatistically significant. Corresponding 95% CI of the slope forCmax included 1, indicating that the less than dose-proportionalincrease in Cmax was not statistically significant. No significantadverse events were observed.  Conclusion Substantial deviation from a dose-proportional increase inAUC(0-inf) and AUC(0-t) suggested a non-linear PK forTMZ-modified release. Single dose of TMZ-modified release was well tolerated andsafe.

drug research

Single Ascending Dose Study to Assess Pharmacokinetic Linearity, Safety, and Tolerability of Trimetazidine - Modified Release in Healthy Human Subjects