Pharmacokinetic Interaction Between Atorvastatin and Hybutimibe in Healthy Chinese Volunteers

Abstract Stains and cholesterol absorption inhibitors are frequently co‐administered in the management of dyslipidemia. This study evaluated the pharmacokinetic (PK) interaction between atorvastatin and hybutimibe in healthy Chinese subjects. A randomized, open‐label, three‐treatment, six‐period crossover study was conducted involving 24 participants. Subjects received once‐daily treatments for 14 days per period (14‐day washout): atorvastatin 20 mg, hybutimibe 10 mg, or their combination. Geometric mean ratios (GMRs) and their 90% confidence intervals (CI) were calculated for the maximum plasma concentration (C max ) and the area under the plasma concentration–time curve (AUC) of atorvastatin, hybutimibe, and their metabolites, comparing combination therapy with monotherapy. At steady state, the GMRs (90% CI) for atorvastatin were 89.9 (74.6, 108.2) for C max and 103.7 (96.0, 112.0) for AUC 0‐∞ when administered with or without hybutimibe. For total hybutimibe, the corresponding values were 120.6 (102.4, 142.0) and 105.7 (97.1, 115.2), respectively. Considering the limited PK changes and good safety profiles of both drugs, the interaction between atorvastatin and hybutimibe will likely have no significant clinical impact.