Open-label, Randomized, Three-fold Crossover Study to Investigate the Bioequivalence of Two Different Tablet Formulations Containing 0.03 mg Ethinylestradiol (EE) and 3 mg Drospirenone (DRSP) Without [SH T470FA] and With [SH T04532A] 0.451 mg Metafolin®, and to Investigate the Bioequivalence of Two Different Tablet Formulations Containing 0.451 mg Metafolin® Without [SH T04532C] and With 0.03 mg EE/ 3 mg DRSP [SH T04532A] in 42 Healthy Young Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation
研究概览
简要总结
The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without Yasmin in the body, in healthy volunteers not using hormonal contraception.
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
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteer
- •Age: 18 - 38 years inclusive
- •Body mass index (BMI)1: ≥ 19 and < 28 kg/m²
- •Regular cyclic menstrual periods at screening OR when using combined oral contraceptives during the recruitment period reporting of natural cyclic menstrual periods prior to their use
- •Willingness to use non-hormonal methods of contraception during the complete trial OR previous tubal ligation
排除标准
- •incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, excretion and effect of the study drugs will not be normal
- •known or suspected sex-steroid influenced malignancies
- •endometrial hyperplasia; genital bleeding of unknown origin; uterus myomatosus
- •known or suspected tumors of the liver and pituitary
- •presence or history of severe hepatic disease as long as liver function values have not returned to normal
- •severe renal insufficiency or acute renal failure
- •thrombophlebitis, venous / arterial thromboembolic diseases; presence or history of prodromi of a thrombosis
- •other conditions that increase susceptibility to thromboembolic diseases
- •known neuropsychiatric diseases, especially known or suspected epilepsy, and/ or deficient status of folate or vitamin B12
- •use of any other medication within 2 cycles before first study drug administration which could affect the study aim
- •use of potassium sparing drugs; use of folic acid containing supplements or medicines or use of any medication within 2 cycles before first study drug administration known to interfere with folate metabolism
- •inadequate folate and/or Vitamin B12 status , clinically relevant deviations in red cell folate concentrations
研究组 & 干预措施
EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)
single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
干预措施: EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) (Drug)
EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)
single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
干预措施: EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) (Drug)
L-5-MTHF Ca 0.451 mg (Metafolin)
single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
干预措施: L-5-MTHF Ca 0.451 mg (Metafolin) (Drug)
结局指标
主要结局
Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation
时间窗: up to 96 hours after administration
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation
时间窗: up to 96 hours after administration
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation
时间窗: up to 168 hours after administration
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Mean Area Under the Concentration-time Curve (AUC) of DRSP Incl. Bioequivalence (BE) Evaluation
时间窗: up to 168 hours after administration
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation
时间窗: up to 12 hours after administration
The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.
Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation
时间窗: up to 12 hours after administration
The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.
Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation
时间窗: up to 12 hours after administration
The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.
Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation
时间窗: up to 12 hours after administration
The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.
次要结局
- Time to Reach Maximum Concentration (Tmax) of EE(up to 96 hours after administration)
- Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP(up to 72 hours after administration)
- Time to Reach Maximum Concentration (Tmax) of DRSP(up to 168 hours after administration)
- Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF(up to 12 hours after administration)