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