Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV), Dienogest (DNG) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 2 mg Estradiol Valerate and 3 mg Dienogest 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
- 43
- 主要终点
- AUC
研究概览
简要总结
Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 2 mg Estradiol Valerate,3 mg Dienogest.Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest 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
- 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
- •Healthy postmenopausal women, age: 45-75 years with body mass index between ≥18 and ≤30 kg/m
- •Post-menopausal state revealed by: medical history, and hormone analyses in serum: estradiol ≤20 pg/mL and in women <60 years old: follicle-stimulating hormone ≥ 40 IU/L at screening
排除标准
- •Contraindications for use of combined (Estradiolvalerate/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
Estradiol + dienogest + levomefolate
Treatment A
干预措施: BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium (Drug)
Estradiol + dienogest
Treatment B
干预措施: BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG) (Drug)
Levomefolate
Treatment C
干预措施: BAY 86-7660,levomefolate calcium (Drug)
结局指标
主要结局
AUC
时间窗: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
Area under the concentration vs time curve from zero to infinity for DNG
Cmax
时间窗: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
AUC(0-tlast)
时间窗: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
AUC from time 0 to the last data point above the lower limit of quantitation for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
次要结局
- tmax(Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C)
- t½(Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C)
- λz(Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C)
- AUC(0-tlast)(Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C)
- AUC(Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C)