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首页> 外文期刊>International journal of clinical pharmacology and therapeutics >A thorough QT/QTc study of multiple doses of tapentadol immediate release in healthy subjects.
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A thorough QT/QTc study of multiple doses of tapentadol immediate release in healthy subjects.

机译：对健康受试者中多次剂量的他喷他多立即释放进行彻底的QT / QTc研究。

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OBJECTIVE: This randomized, double-blind, placebo- and positive-controlled 4-way crossover study evaluated the effects of tapentadol immediate release (IR) on the QT/QTc interval. MATERIALS AND METHODS: Healthy subjects received tapentadol IR 100 mg or 150 mg, or placebo, every 6 h on Days 1 and 2, with a >= 7-day washout between treatments. Moxifloxacin 400 mg was the positive control. Serial triplicate 12-lead electrocardiograms (ECGs) were performed; the Fridericia correction (QTcF) was the primary correction method. Serial blood sampling was performed for pharmacokinetic analyses. RESULTS: Of the 75 subjects who were randomized, 68 received at least 1 dose of study medication, and 59 completed the study. Upper limits of the 90% confidence intervals (CIs) for the difference in mean DeltaQTcF between tapentadol IR 100 or 150 mg and placebo were < 10 ms (non-inferiority criterion) for all time points. The lower limit of the 90% CI for mean DeltaQTcF between moxifloxacin and placebo exceeded 5 ms from 1 to 6 h after dosing, establishing assay sensitivity. No subject had a postdose QTc interval > 480 ms, change from baseline > 60 ms, or clinically relevant change in heart rate or other ECG variables. Steady-state concentrations were reached within 18 to 24 h. Common adverse events were vertigo (central nervous system (CNS) origin), headache, somnolence, nausea, vomiting, and feeling drunk. CONCLUSION: Therapeutic and supratherapeutic doses of tapentadol do not affect the QT/QTc interval.
机译：目的：这项随机，双盲，安慰剂和阳性对照的4交叉研究评估了他喷他多立即释放（IR）对QT / QTc间隔的影响。材料与方法：健康受试者在第1天和第2天每6小时接受100 mg或150 mg的他喷他多IR或安慰剂，治疗之间间隔7天以上。莫西沙星400 mg为阳性对照。进行了三连串的12导联心电图（ECG）; Fridericia校正（QTcF）是主要的校正方法。进行连续血液采样以进行药代动力学分析。结果：在随机分配的75位受试者中，有68位接受了至少1剂研究药物，其中59位完成了研究。在所有时间点，他喷他多IR 100或150 mg与安慰剂之间的平均DeltaQTcF的90％置信区间（CIs）的上限为<10 ms（非劣效性标准）。给药后1至6小时，莫西沙星与安慰剂之间的DeltaQTcF平均值90％CI的下限超过5 ms，从而建立了测定灵敏度。没有受试者的服药后QTc间隔> 480 ms，从基线变化> 60 ms，或心率或其他ECG变量有临床相关变化。在18至24小时内达到稳态浓度。常见的不良事件为眩晕（中枢神经系统（CNS）起源），头痛，嗜睡，恶心，呕吐和喝醉。结论：他喷他多的治疗剂量和治疗剂量不影响QT / QTc间隔。

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