A Multiple Dose Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of 5 g Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Average Plasma Concentration observed (Cav)
研究概览
简要总结
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
详细描述
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Testosterone Gel 1.62%
干预措施: Testosterone Gel 1.62% (Drug)
结局指标
主要结局
Average Plasma Concentration observed (Cav)
时间窗: Up to 24 days
Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol
Maximum Plasma Concentration observed (Cmax)
时间窗: Up to 24 days
Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol
Area Under the Plasma Concentration-time Curve (AUC)
时间窗: Up to 24 days
Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol
Time of Cmax (Tmax)
时间窗: Up to 24 days
Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol
次要结局
- Application site evaluation based on the clinical evaluation of skin reactions grading scale(24 days)
- Adverse events(24 days)