NCT00955760

Study Analyzing the Effect of Rifampicin Administration on the Pharmacokinetics of Neramexane Mesylate

A Single Center, Open-Label, Three Periods, Fixed Sequence Design Study Analyzing the Effect of Rifampicin Administration on the Pharmacokinetics of Neramexane Mesylate

• 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 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 pharmacokinetics of Neramexane. Secondary Objectives: • To assess safety and tolerability of Neramexane single dose treatment alone and co-administration of a Neramexane single dose with a Rifampicin repeated dose treatment.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Neramexane	Drug-Drug Interaction Study

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-08-10
• Last updated: 2011-02-08

Locations

1 site across 1 country: Germany