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- To assess the effects of ascending repeated-doses of oral [p.o.] neramexane at therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc interval) in healthy male and female subjects.
- To assess the pharmacokinetics [PK] of neramexane and N-OH neramexane (if a validated method will be available for this metabolite) following repeated daily doses of 50 mg (steady state), 75 mg (steady state) and 87.5 mg (steady state).
- To assess the safety and tolerability of neramexane 50 mg, 62.5 mg, 75 mg and 87.5 mg repeated-dose treatments when gradually up-titrated in healthy subjects.
- To assess the concentration-QT relationship.
Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)
Parexel International GmbH
Merz Pharmaceuticals GmbH
Published on BioPortfolio: 2014-08-27T03:19:17-0400
Primary: To assess the effects of CYP2B6 inhibition by repeated dose Clopidogrel (75 mg/day) co-administration on the single-dose pharmacokinetics of Neramexane Secondary: T...
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 exc...
Primary Objectives: • Assess the effects of poly-specific cytochrome P450 and drug-transporter induction by repeated dose Rifampicin (600 mg/day) co-administration on the single-dose ...
The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a...
Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between...
We employ a time-dependent Hurst analysis to identify EEG signals that differentiate between healthy controls and combat-related PTSD subjects. The Hurst exponents, calculated using a rescaled range a...
Although nasal congestion is among the most common symptoms in subjects suffering from nasal diseases, relatively few data on normal airflow resistance are available for reference, especially in healt...
Of particular importance for Stratum corneum (SC) lipids are the free fatty acids (FFAs). Age-related changes of the SC structure lead to diminished capacity for barrier compensation. The aims of this...
To compare ultrasound (US) measurements in the sagittal and axial plane of the plantar aponeurosis (PA) in healthy subjects.
It is unclear if individuals with Major Depressive Disorder (MDD) present different nonverbal behavior (NVB) compared with healthy individuals, and also if depression treatments affect NVB. In this st...
Positive test results in subjects who do not possess the attribute for which the test is conducted. The labeling of healthy persons as diseased when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)
Negative test results in subjects who possess the attribute for which the test is conducted. The labeling of diseased persons as healthy when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)
Books intended for use in the study of specific subjects, containing systematic presentation of the principles and essential knowledge of the subjects.
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...