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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Bioequivalence assessment of a single 5 mg/day testosterone transdermal system versus two 2.5 mg/day systems in hypogonadal men.
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Bioequivalence assessment of a single 5 mg/day testosterone transdermal system versus two 2.5 mg/day systems in hypogonadal men.

机译：在性腺功能减退男性中，单个5 mg /天的睾丸激素透皮系统与两个2.5 mg /天的系统的生物等效性评估。

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摘要

A novel, nonscrotal, transdermal delivery system for testosterone therapy has been marketed for treatment of hypogonadal men. The usual dose of this system is two 2.5 mg/day systems applied daily. A new system has been developed that administers a dose of 5 mg/day using a single patch rather than two patches. A randomized, steady-state, four-period, replicate-design, open-label, crossover study was conducted to assess the bioequivalence of the two testosterone transdermal delivery systems in postpubertal, hypogonadal men: two 2.5 mg/day patches as the reference regimen (R) and one 5 mg/day patch as the test regimen (T). 21 men were enrolled, and 20 completed the study. Each subject was randomly assigned to one of four sequences (R1-R2-T1-T2, T1-T2-R1-R2, R1-T1-T2-R2, T1-R1-R2-T2), such that each subject received each regimen during two study sessions. Two subjects were inadvertently treated according to the sequence T1-R1-T2-R2. Patches were applied to the upper arm, thigh, and back in the evening on days 1, 2, and 3, respectively, of each study session. Serial blood samples were obtained for pharmacokinetic analysis of testosterone for 24 hours after patch application on day 3 of each study session. The two formulations would be considered bioequivalent if the 90% confidence intervals (CI) for the ratios of the adjusted geometric means for T:R for both area under the concentration--time curve from 0 to 24 hours (AUC0-24) and maximum concentration (Cmax) were completely contained in the interval (0.80, 1.25). Mean values for AUC0-24 and Cmax were similar for the two formulations. The T and R formulations were found to be bioequivalent based on both AUC0-24 (90% CI 0.96, 1.08) and Cmax (90% CI 0.92, 1.07). The median time to Cmax was also similar, indicating comparable rates of testosterone absorption for both formulations. Based on this analysis, the testosterone transdermal system 5 mg/day patch is bioequivalent to two of the 2.5 mg/day patches. Both systems were safe and well tolerated in hypogonadal men.
机译：用于睾丸激素治疗的新型，非阴囊，透皮递送系统已用于睾丸激素治疗。该系统的通常剂量是每天使用两个2.5 mg /天的系统。已经开发出一种新系统，该系统使用一个贴片而不是两个贴片每天给药5 mg。进行了一项随机，稳态，四周期，重复设计，开放标签，交叉研究，以评估两个青春期性腺功能低下的男性睾丸激素透皮给药系统的生物等效性：以两个2.5 mg /天的剂量作为参考方案（R）和一个5 mg / day的贴剂作为测试方案（T）。招募了21名男性，其中20名完成了研究。每个受试者随机分配到四个序列之一（R1-R2-T1-T2，T1-T2-R1-R2，R1-T1-T2-R2，T1-R1-R2-T2），这样每个受试者都接受了在两个学习环节中的治疗方案。根据序列T1-R1-T2-R2对两名受试者进行了疏忽治疗。在每个研究阶段的第1、2和3天晚上分别在上臂，大腿和背部贴上补丁。在每个研究阶段的第3天，在贴片应用后24小时内获取连续血样，用于睾丸激素的药代动力学分析。如果浓度-时间曲线从0到24小时（AUC0-24）和最大浓度下的两个区域的T：R的调整几何平均值之比的90％置信区间（CI），则将这两种制剂视为生物等效浓度（Cmax）完全包含在区间（0.80，1.25）中。两种配方的AUC0-24和Cmax平均值相似。基于AUC0-24（90％CI 0.96，1.08）和Cmax（90％CI 0.92，1.07），发现T和R制剂具有生物等效性。 Cmax的中值时间也相似，表明两种制剂的睾丸酮吸收率相当。根据该分析，睾丸激素透皮系统5 mg /天的贴剂与2.5 mg /天的贴剂中的两个生物等效。性腺功能减退的男性，这两种系统都是安全的，并且耐受性良好。

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