NCT01359163已完成1 期
An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Commercial Femulen Tablets Versus Reformulated Femulen Tablets In Healthy Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area under the curve to last time point observed (AUCt)
研究概览
简要总结
A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- •Healthy female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
研究组 & 干预措施
Femulen commercial tablets
Active Comparator
干预措施: etynodiol diacetate (Drug)
Femulen reformulated tablets
Experimental
干预措施: etynodiol diacetate (Drug)
结局指标
主要结局
Area under the curve to last time point observed (AUCt)
时间窗: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Highest concentration (Cmax)
时间窗: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
次要结局
- Area under the curve to infinity (AUCinf)(0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48)
- Area under the curve percent to infinity (AUC%inf)(0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48)
- Half-life (T1/2)(0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48)
- Time at maximum concentration (Tmax)(0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48)
研究者
研究点 (1)
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