NCT01073904已完成1 期
Open-label, Randomized, Crossover Study to Prove the Bioequivalence Between Opxion® (Levonorgestrel 1.5 mg Coated Tablet From Bayer de Mexico) and Postinor 2® (Levonorgestrel 1.5 mg Tablet From Biofarma Natural CMD) in Healthy Volunteers
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
- Bayer
- 入组人数
- 32
- 主要终点
- Least square estimator of average maximum plasmatic concentration (log transformed)
研究概览
简要总结
A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods. Treatment groups are balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis.
排除标准
- •History of illnesses or any organic abnormalities that could affect the results of the study.
- •History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs.
- •Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Levonorgestrel Emergency Pill (BAY86-5028) (Drug)
Arm 2
Active Comparator
干预措施: Postinor 2 (Drug)
结局指标
主要结局
Least square estimator of average maximum plasmatic concentration (log transformed)
时间窗: After 2 months
Least square estimator of area under the pharmacokinetic curve (log transformed)
时间窗: After 2 months
次要结局
- Time at which maximum concentration is reached(After 2 months)
- Area under the pharmacokinetic curve from time=0 to last blood sample(After 2 months)
- Half life of plasmatic concentration of study drug(After 2 months)
- Clearance constant of plasmatic concentration of study drug(After 2 months)
- Adverse events collection(Up to 8 weeks)
研究者
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