NCT00319163已完成1 期
An Open-label, Single-dose, Randomized, 2-period, Crossover, Bioequivalence Study to Compare Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling 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 26 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound
研究概览
简要总结
Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE.
Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18 - 35 years of age
- •Non-smokers
排除标准
- •History of thromboembolic disease
- •Prior adverse experiences with oral contraceptives
结局指标
主要结局
Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound
次要结局
- Additional safety--clinical labs
- electrocardiograms (ECGs)
- vital signs
- and adverse event recording over 4 days following administration of each formulation (LNG/EE)
研究者
研究点 (1)
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