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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...
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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)
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Books intended for use in the study of specific subjects, containing systematic presentation of the principles and essential knowledge of the subjects.
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