Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 3 mg EV Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 42
- 主要终点
- Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF
研究概览
简要总结
Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 3 mg Estradiol Valerate Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI:>18 <30 kg/m²
- •Healthy female volunteers
- •Age 45-75 years
- •Postmenopausal state
排除标准
- •Contraindications for use of combined (Estradiol Valerate/dienogest) contraceptive (e.g.history of venous/arterial thromboembolic disease)
- •Regular intake of medication
- •Clinically relevant findings (ECG, blood pressure, physical and gynaecological examination, laboratory examination)
研究组 & 干预措施
Arm 2
干预措施: Estradiol Valerate (EV) (BAY86-4980) (Drug)
Arm 1
干预措施: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078) (Drug)
Arm 3
干预措施: Levomefolate Calcium (BAY86-7660) (Drug)
结局指标
主要结局
Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF
时间窗: 2 months
次要结局
未报告次要终点