An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Bazedoxifene/Conjugated Estrogens (Premarin Current Process) And Bazedoxifene/Conjugated Estrogens (Premarin New Process) In Healthy Postmenopausal Women

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2007年3月1日最近更新: 2007年12月28日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
主要终点: PK results

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Bazedoxifene/Conjugated Estrogens (BZA/CE) is an investigational drug that is being developed for treatment of menopause. The purpose of this trial is to compare a new manufacturing process for making BZA/CE to the current process by assessing the way it is absorbed into the blood.

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
•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
•Healthy as determined by the investigator on the basis of medical history, physical examination, breast and gynecologic examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

排除标准

•Any clinically important active condition of gynecologic, cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
•History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
•History of any clinically important drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs).

结局指标

主要结局

PK results

次要结局

未报告次要终点

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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