NCT00788047

A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan

A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This drug-drug interaction study is being conducted to evaluate the potential effect of Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450 2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.

Conditions

• Huntington Disease
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Dextromethorphan	Dextromethorphan HCl 30 syrup single dose
DRUG	Dimebon + Dextromethorphan	Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-11-10
• Last updated: 2009-03-09

Locations

1 site across 1 country: United States