Evaluation of Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of Neramexane Mesylate in Healthy Japanese Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Part 1 (single dose) Primary parameters * Area under the plasma concentration curve from zero to infinity \[AUC0-inf\] and observed maximum plasma concentration \[Cmax\] of Japanese and Caucasian subjects for each dose group * If at least 20% of the Japanese or of the Caucasian subjects have an area under the plasma concentration curve extrapolation \[AUCextrap%\] \>20% relative to AUC0-inf for one of the dose groups area under the plasma concentration curve from zero to the last measurable concentration \[AUC0- tz\] becomes primary parameter for Japanese and Caucasian subjects for all of the dose groups. In this case AUC0-tau will become a secondary parameter Secondary parameters and derived values from statistical analysis * Dose proportionality and linearity in Japanese subjects * Ratios (Japanese vs. Caucasian subjects) of AUC0-∞ and Cmax for each dose group * Dose normalized AUC \[AUC0-inf,norm\], dose normalized Cmax \[Cmax,norm\], AUC0- tz, time of occurrence of Cmax \[tmax\], apparent terminal half life \[t½\], mean residence time \[MRT\], apparent (oral) total plasma clearance \[CLtot/f\], apparent volume of distribution during the terminal disposition phase \[Vz/f\], AUCextrap%, apparent terminal disposition rate constant \[λz\], weight corrected AUC0-inf, weight corrected AUC0-tz, weight corrected Cmax, weight corrected CLtot/f, cumulative amount of excreted Neramexane into urine \[Ae0-tz\], fraction of orally administrated drug excreted into urine \[fe/f\], renal clearance \[CLR\] and apparent non-renal clearance \[CLNR/f\] * Safety and tolerability Other parameters * Pharmacogenetics * Amount of N-OH Neramexane excreted in urine \[Ae0-tz\] if a validated method will be available at the time of analysis * Metabolite determination (N-OH Neramexane) in plasma and urine, optional (may be analyzed and evaluated if a validated method will be available at the time of analysis) * Endogenous creatinine clearance \[CLCR\], amount of excreted creatinine into urine per hour \[AeCR,hr\] * Evaluation of further metabolites will be described in detail in the Statistical Analysis Plan

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Last update posted Apr 14, 2011 · Synced Sep 4, 2026

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