NCT00400335已完成1 期
An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- lab tests for relative bioavailability of testosterone and dutasteride,
研究概览
简要总结
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Are healthy.
- •Have a BMI within range of 19-32 kg/m
- •Have not taken dutasteride for one year, or finasteride for the past 3 months.
- •Have a screening PSA < 2.0ng/mL.
排除标准
- •Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition.
- •Have a trigliceride level =500mg/dL.
- •Have abnormal thyroid or hormone levels.
- •Would donate more than 500 ML of blood over a 2 month period.
- •Physician does not think it is a good idea for you to participate in the trial.
- •Are unwilling to abstain from alcohol during the study.
- •Have a positive urine drug screen test.
- •Plan to change your smoking habits during the course of the trial.
- •Have Hepatitis C, Hepatitis B, or HIV.
- •Have a lab or ECG abnormality.
- •Have high or low blood pressure.
- •Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
结局指标
主要结局
lab tests for relative bioavailability of testosterone and dutasteride,
时间窗: days 1, 2, 3, 19, 20, 21 & 26-31
次要结局
- lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,(days 1, 2, 3, 19, 20, 21 & 26-31.)
- safety lab tests of various testosterone/dutasteride formulations,(days 1, 2, 3, 19, 20, 21 & 26-31.)
研究者
研究点 (1)
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