NCT00901290暂停1 期
A Randomized, Open-Label, Two-way Crossover Study to Determine the Effects of Co-administration of AZD7325 and a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate 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
- 暂停
- 发起方
- AstraZeneca
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN
研究概览
简要总结
The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •If previously pregnant, must be > 6 month post-partum at the time of randomization
- •Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m2
排除标准
- •Use of any prescription medication within 14 days of screening
- •current smoker or history of smoking within the last 3 months prior to enrollment
- •Abnormal pap smear exam result within one year of enrollment.
研究组 & 干预措施
1
Experimental
monophasic oral contraceptive
干预措施: monophasic oral contraceptive (Drug)
2
Experimental
AZD7325
干预措施: AZD7325 (Drug)
结局指标
主要结局
To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN
时间窗: weekly
次要结局
- Characterize the pharmacokinetics of progesterone, luteinizing hormone, follicle-stimulating hormone, and sex hormone binding globulin following dosing with monophasic oral contraceptive (ORTH-CYCLEN) alone and following co-administration with AZD7325(weekly)
- To characterize the steady-state pharmacokinetics of AZD7325(weekly)
- To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN)(weekly)
研究者
研究点 (1)
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