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首页> 外文期刊>Clinical drug investigation >Lack of interaction between modified-release fluvastatin and amlodipine in healthy subjects
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Lack of interaction between modified-release fluvastatin and amlodipine in healthy subjects

机译：在健康受试者中，缓释氟伐他汀与氨氯地平之间缺乏相互作用

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Objective: To investigate the potential for a pharmacokinetic interaction between fluvastatin modified-release 80mg tablet (Lescol~R XL; fluvastatin XL) and amlodipine 5mg tablet (Norvasc~R) following multiple once-a-day doses for 2 weeks.Design: This was a single-centre, six-sequence, three-period, randomised, cross over design study. Fluvastatin XL 80mg tablet and amlodipine 5mg tablet were administered once a day for 2 weeks either alone or in combination. Fluvastatin and amlodipine serum concentration profiles were characterised on day 14 for each treatment. The pharmacokinetic interaction between the two drugs was evaluated based on the p-values and 90% confidence intervals (CIs) for log-trans formed highest observed concentration (C_(max)), area under the plasma concentra tion-time curve calculated by the linear trapezoidal method up to 24 hours (AUC_(24)), and apparent oral clearance at steady state (CL/F), using a single entity as the reference treatment and the combination as the test treatment. Adverse events (AEs), safety laboratory tests and physical examinations were evaluated for safety.Study participants: Twenty-four healthy subjects were enrolled and 19 complet ed the study. The safety analysis was based on data from all 24 subjects who received at least one dose of a treatment, while the pharmacokinetic analysis was based on data from the 19 subjects who completed all treatments.Results: The coadministration of fluvastatin XL and amlodipine resulted in no significant changes in the steady-state AUC (469 vs 454mug center dot h/L), C_(max) (96 vs 89 mug/L), and CL/F (197 vs 232 L/h) of fluvastatin when compared with fluvastatin XL alone. The p-values for these comparisons were between 0.172 and 0.238, and the 90% CIs for the geometric means were within 78% and 139%. A similar comparison for amlodipine showed no significant difference in the steady-state AUC (132 vs 140mug centre dot h/L), Cmax (7.1 vs 7.5 mug/L) and CL/F (41 vs 40 L/h) of amlodipine. The p-values for these comparisons were between 0.309 and 0.353, and the 90percent CIs for the geometric means were within 90percent and 111percent. The majority of the AEs were mild in severity. There were no clinically relevant changes in clinical laboratory results, physical examinations or vital sign para meters.Conclusion: There were no significant differences in the steady-state pharmaco-kinetics of fluvastatin or amlodipine when they were administered together and the small differences observed were not clinically relevant. Therefore, no dose adjustment of either drug is necessary when fluvastatin and amlodipine are coadministered.
机译：目的：研究每日两次多次服用氟伐他汀缓释80mg（Lescol〜R XL;氟伐他汀XL）与氨氯地平5mg片剂（Norvasc〜R）之间的药代动力学相互作用的潜力。是一项单中心，六序列，三周期，随机，交叉设计研究。氟伐他汀XL 80毫克片剂和氨氯地平5毫克片剂每天一次给药，连续2周，可单独给药或联合给药。在每种治疗的第14天，对氟伐他汀和氨氯地平的血清浓度进行了表征。根据p值和90％置信区间（CIs）对数转化形成的最高观察浓度（C_（max））评估血浆药物浓度-时间曲线下面积的两种药物之间的药代动力学相互作用。线性梯形方法长达24小时（AUC_（24）），并且在稳态下具有明显的口腔清除率（CL / F），使用单个实体作为参考治疗，联合使用作为测试治疗。评估了不良事件（AEs），安全实验室测试和身体检查的安全性。研究参与者：纳入24名健康受试者，完成19项研究。安全性分析是基于来自接受至少一剂治疗的所有24名受试者的数据，而药代动力学分析是基于来自完成所有治疗的19名受试者的数据。结果：氟伐他汀XL和氨氯地平的共同给药未导致与氟伐他汀相比，氟伐他汀的稳态AUC（469 vs 454ugug中心点h / L），C_（最大值）（96 vs 89 cup / L）和CL / F（197 vs 232 L / h）有显着变化加大码。这些比较的p值在0.172和0.238之间，几何平均值的90％CI在78％和139％之内。氨氯地平的类似比较显示，氨氯地平的稳态AUC（132 vs 140杯中心点h / L），Cmax（7.1 vs 7.5杯/升）和CL / F（41 vs 40 L / h）没有显着差异。这些比较的p值在0.309和0.353之间，几何均值的90％置信区间在90％和111％之内。大部分AE轻度。结论：氟伐他汀或氨氯地平合用时的稳态药代动力学无显着差异，观察到的细微差异无统计学意义。临床相关。因此，当氟伐他汀和氨氯地平合用时，无需调整任何一种药物的剂量。

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