NCT01137708已完成1 期
A Phase 1, Randomized, Open Label, 2-Way Crossover Study To Assess The Effect Of Multiple Dose CP-690,550 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids 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
- AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN)
研究概览
简要总结
This study is designed to assess whether co-administration of CP-690,550 and oral contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects
- •No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis
排除标准
- •Any medical reason which would contraindicate the administration of oral contraceptives
- •Clinically significant infections within the past 3 months or history of febrile illness within 5 days
- •Positive screening test for Hepatitis B surface antigen, anti Hepatitis C antibody, or human immunodeficiency virus
- •Pregnant or nursing women, and women of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception
研究组 & 干预措施
Treatment Sequence 1
Experimental
干预措施: ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN) (Drug)
Treatment Sequence 2
Experimental
干预措施: CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN) (Drug)
结局指标
主要结局
AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN)
时间窗: 12 days
次要结局
- AUClast, Cmax, Tmax, and t½ of ethinyloestradiol (EE) and levonorgestrel (LN)(12 days)
- Number of adverse events and number of participants with adverse events(12 days)
- Changes in complete blood count and serum chemistry profile(12 days)
- Changes in vital signs(12 days)
研究者
研究点 (1)
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