NCT00745173已完成1 期
An Open-Label, Single/Multiple Dose Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Conjugated Estrogens (CE) On Bazedoxifene In Healthy Postmenopausal Women.
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年9月最近更新:
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
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet when administered together with multiple doses of Premarin (conjugated estrogens or CE) to healthy postmenopausal women.
Information will also be obtained regarding the safety and tolerability of this combination in healthy, postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •For inclusion into the study, women must be healthy and postmenopausal (either naturally or surgically) between the ages of 35 and 70, inclusive.
- •Blood hormone levels must be consistent with a postmenopausal state (for specified subjects).
- •They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able to abstain from smoking during clinic confinements
排除标准
- •A subject will be excluded from participation if they :
- •Have participated in a clinical drug study within 30 days prior to study medication administration;
- •Have a history of drug or alcohol abuse within 1 year or consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine);
- •Donate any other plasma or blood during the total study.
研究组 & 干预措施
1
Other
干预措施: Premarin (Drug)
结局指标
主要结局
Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters
时间窗: 3 months
次要结局
- To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population.(3 months)
研究者
研究点 (1)
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