A Randomized, Open, Crossover bioequivalence study and Food Effect Assessment of Two fixed-dose combination of Lisinopril / Amlodipinebesylatein Healthy Chinese Subjects

Background:This study was conducted to compare the PK characteristics, food effect and evaluate the bioequivalence between two fixed-dose combinations of lisinopril /amlodipine besylate in healthy Chinese subjects. Methods: A single center, randomized, open-label, single-dose, crossover bioequivalence study was designed in healthy Chinese subjects under both fasting and fed conditions. Cmax and AUC were used to evaluate bioequivalence. Adverse events were recorded. Results: 75 healthy subjects completed the study. The 90% confidence intervals of the ratio of geometric means of Cmax and AUC0-∞ of lisinopril and amlodipine fell within 0.80-1.25. A fat-high breakfast produced significant alteration in the Cmax and AUC of lisinopril after a dose of either reference or test drug. No severe adverse events were observed. Conclusion: The trial demonstrated that the test and the reference drug of fixed-dose combinations of lisinopril /amlodipine besylate were bioequivalent and well tolerated under fasting and fed condition