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Changes in the Renal Excretion of Neramexane by Acidification of Urinary pH Study With and Without Application of a Urinary pH Acidification Regimen

NCT00972127 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2011-02-07

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Neramexane

25 mg or 2x25mg tablets

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Study Design

Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00972127 on ClinicalTrials.gov