NCT00550433已完成1 期
An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Clinical and Commercial Formulations of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 主要终点
- The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.
研究概览
简要总结
The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women aged 35 to 70 years.
- •Spontaneous or surgical amenorrhea for at least 6 months.
- •Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg.
排除标准
- •Hypertension or elevated supine blood pressure (>139 mm Hg systolic or >89 mm Hg diastolic).
- •History of any clinically important drug allergy.
- •Use of any prescription or investigational drug within 30 days before test article administration.
结局指标
主要结局
The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.
次要结局
未报告次要终点
研究者
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