NCT00972127已完成1 期
Changes in the Renal Excretion of Neramexane by Acidification of Urinary pH Open-Label, Randomized, Single Center, Multiple Dose, 2-Period, 2-Sequence, Crossover Study With and Without Application of a Urinary pH Acidification Regimen
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
研究概览
简要总结
Primary:
- To assess the influence of acidified urinary pH on the renal excretion of Neramexane
Secondary:
- To assess the influence of acidified urinary pH on the renal excretion of N-OH Neramexane
- To assess the steady state plasma pharmacokinetics (PK) of Neramexane and N-OH Neramexane under physiological conditions and under the conditions of urine acidification
- To assess safety and tolerability of a repeated dose treatment of Neramexane under physiological conditions and under the conditions of urine acidification
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult subject of any ethnic origin, who is able to read, to write and fully understand German language
- •Aged 18 to 45 years
- •BMI of 18-28 kg/m2 and a body weight of 50-90 kg
- •Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study
- •Female subject of childbearing potential must agree to use an effective method of birth control such as sexual abstinence, vasectomised partner, non hormonal IUDs or double contraception methods (e.g., condom with spermicide cream)
排除标准
- •History of clinically relevant allergy or known hypersensitivity to Neramexane/Memantine/Amantadine and their derivatives
- •History of clinically relevant allergy or known hypersensitivity to Ammonium Chloride
- •Exposure to another investigational agent within the last two months before Day 1 of Period 1
- •History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used investigational products or tool substances
- •Lactating or pregnant female or female planning to become pregnant during study conduct or within 2 months after end of study. Male planning to beget children during study conduct or within 2 months after end of study
- •Any contraindications which are indicated in the topically valid SPC for Extin®N: acidosis, gastritis, gastro-intestinal ulcer, hepatic or renal insufficiency, hypokalemia
- •Lack of suitability for the trial
- •Any evidence of a significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrinological, metabolic (acidosis), psychiatric or other disease at screening
- •History of malignancy
- •Any clinically relevant deviation in clinical or laboratory assessment
- •Clinically relevant abnormalities in the 12-lead ECG which in the discretion of the investigator and the Merz scientific expert might affect the study objectives
- •Systolic blood pressure <95 mmHg or >150 mmHg or diastolic blood pressure < 50 mmHg or >90 mmHg in supine position
- •Pulse rate <45 or >100 beats per minute
- •Clinically relevant chronic or acute infections
- •Acute or chronic disease, especially psychiatric or neurologic disorders
- •Current evidence of hypokalemia (= below lower limit of laboratory normal range plus 0.3 mmol/l as safety margin)
- •History of alcohol or drug dependence within the last 2 years
- •Alcohol consumption averaging more than 40 g for male and more than 20 g for female subject daily within the last year
- •Regular caffeine consumption averaging more than 1 L of coffee and/or tea daily or more than 1 L of caffeine-containing lemonades per day within the last year
- •Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal products (e.g. acute inflammations, gastrointestinal disease, cholecystectomy, resection of small or large intestine, etc.)
- •Use of any prescribed medication for four weeks prior to the first administration of IMP.
- •Regular use of over-the-counter [OTC] drugs in the 4 weeks prior to the first administration of the IMP
- •Occasional use of OTC drugs (except paracetamol, maximum 1 g/day) within the 2 weeks prior to the first administration of the IMP
- •Stable intake of thyroid hormone substitution will be allowed.
- •Use of any food, food supplement or medication known to induce or inhibit CYP3A4 or other cytochrome P450 enzymes within two weeks preceding the start of the study (Day 1), e.g. grapefruit, St. John's wort
- •Special diet, e.g. vegetarian
- •Female subject who employed any form of hormonal contraception within 2 months prior to Day 1 (e.g. oral contraceptives, hormone releasing intrauterine contraceptive devices [IUDs], etc.)
- •Consume of xanthine derivates (including caffeine) within two days prior to Day 1
- •Smoker and user of snuff, nicotine replacement and chewing tobacco
- •Previous enrolment into the clinical phase of the current study
- •Positive results in any of the serology tests
- •Blood donation of more than 450 mL within 60 days prior to Day 1
- •Positive pregnancy test, if female
- •Positive drug screen or alcohol test
- •Administrative reasons
- •Lack of willingness or inability to co-operate adequately
- •Employee or direct relative of an employee of the CRO or Merz Pharmaceuticals GmbH
- •Lack of ability or willingness to give informed consent
- •Vulnerable subject (e.g. person kept in detention)
- •Anticipated non-availability for study visits/procedures
- •Inability to follow study procedures and investigator instructions adequately
研究者
相似试验
进行中（未招募）
1 期
The effects of increased renal function on the blood concentration dynamics of antibiotic piperacillin/tazobactamThe state of renal hyperfiltration during infection in children and young adults with malignant or non-malignant haematological or oncological diagnosisEUCTR2016-003374-40-EEniversity of Tartu56
尚未招募
2 期
Clinical study to evaluate the role of urine pH in UrolithiasisCTRI/2024/06/069123White Memorial Homoeo Medical College and Hospital
已完成
2 期
Assesment of the effect of tranexamic acid on perioperative bleeding in patients undergoinig adenotonsillectomyAdenoid.Hypertrophy of adenoids and Enlargement of adenoidsIRCT20180404039191N1Zahedan University of Medical Sciences160
招募中
不适用
Examination of the effects on renal function and prognosis of various diuretics for liver cirrhosisiver cirrhosisJPRN-UMIN000040179Hokkaido University400
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 SubjectsHealthyNCT00915174Merz Pharmaceuticals GmbH36