NCT00972127

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Neramexane	25 mg or 2x25mg tablets

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-09-04
• Last updated: 2011-02-07