Bioequivalence Study of Single-Pill Capsule Formulation of Amlodipine Plus Benazepril in Healthy Chinese Subjects Under Fasting and Fed Conditions

• DOI: 10.2147/dddt.s498337
• Publication Date: 2025-03-13T10:45:21Z
• Authors: Haojing Song; Bo Qiu; Xue Sun; Caihui Guo; Yiting Hu; Zhanjun Dong; Yang Liu; Wanjun Bai
• Keywords: Benazepril; Amlodipine; Bioequivalence; Pill; Capsule

The aim of the study was to evaluate pharmacokinetic (PK) properties and safety profiles test reference amlodipine/benazepril capsules under both fasting fed states, determine bioequivalence between two formulations, provide sufficient evidence for new drug application. conducted utilizing a randomized, open-label design, involving formulations administered in single-dose format. Healthy Chinese participants who met eligibility criteria were single dose or capsule. Blood samples taken serially up 168 hours post-administration during each period, plasma levels amlodipine, benazepril, benazeprilat measured using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. For evaluation, geometric mean ratios comparing parameters with those calculated along their corresponding 90% confidence intervals. Safety assessments throughout duration study. PK formulation found be comparable conditions. intervals (CIs) peak concentration (Cmax), area curve from time zero last measurable (AUC0-t), observed infinity (AUC0-∞) fell within range 80.00% 125.00% groups. Both well tolerated by participants, no serious adverse events reported trial. healthy individuals confirmed meeting regulatory standards set demonstrated tolerability.