NCT01063023已完成1 期
Effect of BMS-650032 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri- Cyclen (R)) in Healthy Female Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年1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
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)
研究概览
简要总结
To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug
排除标准
- •Abnormal pap smear within 1 year prior to day 1
- •Any significant or chronic uncontrolled medical illness
研究组 & 干预措施
Arm A - Ortho Tri-Cyclen®
Active Comparator
1 to 28 days
干预措施: Ortho Tri-Cyclen® (Drug)
Arm B - Ortho Tri-Cyclen®
Active Comparator
29 to 56 days
干预措施: Ortho Tri-Cyclen® (Drug)
Arm C - Ortho Tri-Cyclen® + BMS-650032
Active Comparator
Ortho Tri-Cyclen®: 57 to 77 days
BMS-650032: 68 to 77 days
干预措施: Ortho Tri-Cyclen® (Drug)
Arm C - Ortho Tri-Cyclen® + BMS-650032
Active Comparator
Ortho Tri-Cyclen®: 57 to 77 days
BMS-650032: 68 to 77 days
干预措施: BMS-650032 (Drug)
结局指标
主要结局
Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)
时间窗: 24 hours of dosing
次要结局
- To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered(Safety will be assessed through day 78)
- To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination(PK assessments will be done on Day 49, 50, 77 and 78)
研究者
研究点 (1)
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