NCT00915174已完成1 期
Study to Evaluate the Effects of Neramexane on the Pharmacokinetics of a Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Healthy Female Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Area Under Curve within a dose interval (AUC, 0-tau) and Maximum Plasma Concentration at Steady State (Cmax) of Drospirenone (DRSP) and Ethinyl Estradiol (EE)
研究概览
简要总结
Primary:
To assess the effects of repeated dose of Neramexane on the steady-state pharmacokinetics of Drospirenone [DRSP] and Ethinyl Estradiol [EE]
Secondary:
To assess safety and tolerability of concomitant repeated dose treatments of Neramexane and a fixed-combinational DRSP- and EE-containing oral contraceptive [OC] (Yasmin®)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy adult female subject of child bearing potential (including subject with tubal ligation), white origin, who is able to read, to write and fully understand German language
- •Aged 18 to 45 years (both inclusive)
- •BMI of 18-28 kg/m2 and a body weight of 50-90 kg (both inclusive)
- •The subject is required
- •To have taken a DRSP/EE- containing OC for at least two dosing cycles
- •To agree using reliable non hormonal birth control methods from Day -1 of study Period 1 until the Final Examination (e.g. non-hormonal IUD, double barrier method [e.g. condom with spermicide or diaphragm with spermicide], sexual abstinence). Women with tubal ligation or sterilized partner do not need an additional birth control method
- •Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study
排除标准
- •History of clinically relevant allergy or known hypersensitivity to Neramexane/Memantine/ Amantadine and their derivatives
- •Hypersensitivity to Quinine
- •History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used study medications (Neramexane, Yasmin®, Placebo) or tool substance
- •History of clinically relevant allergy or known hypersensitivity to DRSP/EE
- •Clinically relevant findings on the mammae or genital examination, PAP smear ≥ III
- •Any contraindications against the oral contraceptive:
- •present or past venous thromboses (deep vein thrombosis, pulmonary embolism);
- •present or past arterial thromboses (e.g. myocardial infarction) or their prodromal stages (e.g. angina pectoris and transitory ischaemic attack);
- •present or past cerebrovascular insult;
- •presence of a serious risk factor or several risk factors for an arterial thrombosis: diabetes mellitus with vascular changes, severe hypertension, severe lipid metabolism disturbance;
- •known or suspected genetic or acquired predisposition for venous or arterial thromboses like APC resistance,
- •known or suspected genetic lack of antithrombin III, lack of protein C, lack of protein S, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulants);
- •present or past pancreatitis if this is accompanied by severe hypertriglyceridaemia;
- •present or past severe hepatic disease as long as the liver function tests have not normalized;
- •severe renal insufficiency or acute renal failure;
- •present or past hepatic tumors (benign or malign);
- •known or suspected sexual hormone dependent, malign tumors (e.g. of the genital organs or the mamma);
- •diagnostic not clarified vaginal bleedings;
- •anamnesis of migraine with focal neurologic symptoms;
- •known hereditary angioedema
- •Exposure to another investigational agent within the last two months before Day 1 of Period 1
结局指标
主要结局
Area Under Curve within a dose interval (AUC, 0-tau) and Maximum Plasma Concentration at Steady State (Cmax) of Drospirenone (DRSP) and Ethinyl Estradiol (EE)
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (2)
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