NL-OMON40637已完成不适用
An open-label, multiple-dose, sequential, 2 treatment period study to evaluate the effect of QBW251 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in pre-menopausal healthy female volunteers - CQBW251X22102 (CS0216)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy premenopausal female subjects age 18 to 50 years of age. Stable regimen of monophasic OC containing EE (30 µg)/LVG (150 µg) for at least three cycles prior to dosing in treatment period.;Any Subject not taking any OC or taking another brand of;monophasic OC (which does not contain 30 µg EE and 150 µg LVG);should be willing to take a monophasic OC containing 30 µg EE and;150 µg LVG for at least three cycles during synchronization until day -7.;Negative pregnancy test results at screening and both baseline;visits.
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.;Women of child-bearing potential, defined as all women;physiologically capable of becoming pregnant, unless they are using contraception methods.;Women who are either heterozygous or homozygous for the Factor V Leiden mutation.
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