NCT02146391已完成1 期
AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF FOOD UPON THE PHARMACOKINETICS OF ANDROXAL
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- • Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state.
研究概览
简要总结
This study is an open-label, randomized, single-center, single-dose, two-way crossover study of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each receive a single dose of Androxal 25 mg in both the fed and fasting state.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- •Male; age 18-60 with a BMI of 25-42 kg/m2 inclusive
- •No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
- •Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
- •Subject is willing to remain in the clinic for the screening visit and 2 overnight treatment visits (approximately 36 hours for the treatment visit)
- •Must be able to swallow gelatin capsules;
- •Must be willing to remain in the clinic for the treatment visits
排除标准
- •Known hypersensitivity to Clomid;
- •Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
- •A hematocrit >54% or a hemoglobin >17 g/dL.
- •Subject with a significant organ abnormality or disease as determined by the Investigator;
- •Any medical condition that would interfere with the study as determined by the Investigator;
- •Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
- •An acute illness within 5 days of study medication administration;
- •Positive urine drug screen at the screening visit;
- •Known history of HIV and/or Hepatitis B or C
- •Tobacco (nicotine products) use in the 3 months prior to the study;
- •A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
- •History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
- •History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation;
- •An employee or family member of an employee of the study site or the Sponsor;
- •Previous participation in a clinical study of Androxal.
研究组 & 干预措施
Androxal 25 mg
Experimental
干预措施: Androxal 25 mg Capsules (Drug)
结局指标
主要结局
• Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state.
时间窗: 24 hour
次要结局
未报告次要终点
研究者
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