Author:
Li Ting,Liu Yan-ping,Liu Shu-qin,Shi Ping,Jiang Xin,Tao Ye,Gao Xiao-meng,Ma Ya-ping,Cao Yu
Abstract
Abstract
Purpose
The combination of lisinopril and amlodipine has a marked additional effect on blood pressure and fewer side effects than individual monotherapy. This study was conducted to compare the pharmacokinetic parameters and evaluate the bioequivalence between two Lisinopril/amlodipine tablets in healthy Chinese subjects.
Methods
A single center, randomized, open-label, single-dose, two-period crossover bioequivalence study was designed in healthy Chinese subjects under both fasting and fed conditions. Blood samples were collected before drug administration and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 24, 36, 48, 72, 96, 144, 168 h after administration. Liquid chromatography-tandem mass spectrometry (LC–MS/MS) was applied to determine the plasma concentration of lisinopril and amlodipine. Maximum concentration (Cmax) and area under the concentration–time curve (AUC) were used to evaluate bioequivalence. Adverse events were recorded.
Results
Ninety-two healthy subjects were enrolled, and 75 completed the study. The 90% confidence intervals (CIs) of the ratio of geometric means (GMRs) of Cmax, AUC0-t, and AUC0-∞ of lisinopril and amlodipine under both fasting and fed conditions fell within the conventional bioequivalence criteria of 0.80–1.25. A high-fat meal appeared to decrease the Cmax and AUC of lisinopril. No severe adverse events were observed.
Conclusion
The trial demonstrated that the test and the reference lisinopril/amlodipine tablets were bioequivalent and well tolerated in Chinese people under fasting and fed conditions.
Trial registration
Clinical Trails.gov identifier, NCT04885660 (retrospectively registered in 13/05/ 2021).
Funder
National Major Scientific and Technological Special Project for “Significant New Drugs Development”
Natural science foundation of Shandong province
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology
Cited by
2 articles.
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