A new enalapril modified release formulation shows comparable pharmacodynamic profile to the referencie drug in healthy subject Phase I

OTTAVIANO G; TURMARKIN M; OTERO-LOSADA, MATILDE; ROLDAN E; AZZATO F; MULLER A; MILEI J

Paris

Congreso; 26th European Meeting on Hypertension and Cardiovascular Protection; 2016

ESH Meetin European

The aim of this study was to compare the pharmacodynamic profile of two newformulations of enalapril (modified release) with the standard reference drug.Six healthy volunteers, both sexes, participated in this single dose, open, randomizedstudy using a cross-over design with treatment as a within-subjects factor. Each subjectreceived 5 sequential treatments of enalapril maleate matching 5 formulation-dosecombinations: Reference treatment (Renitec 20 mg, Merck & Co Inc), T1 (formulation A20 mg), T2 (formulation B 20 mg), T3 (formulation A 10 mg), and T4 (formulation B 10mg), with a 7-day washout period to achieve full drug clearance between consecutivetreatments. Blood samples were obtained every 8 h for 24 h starting from the baseline (4samples/subject) for determination of renin concentration, renin activity, andangiotensin convertase enzyme (ACE) activity. A 24-h ambulatory blood pressuremonitoring was recorded. Results were submitted to ANOVA, expressed as mean ± SDfor each treatment, and between-treatment comparison was performed usingBonferroni t test