NCT00584779

An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package insert to Japanese.

Detailed description

The study was terminated on September 30, 2008 at the current study site due to reported adverse events in the study subjects (n=8). While the adverse events reported were generally consistent with the known profile of gabapentin, it was decided that the study should continue at a different study site. The pharmacokinetics of gabapentin in the subjects with renal impairment will be evaluated in a separate study with a different study number at a different site. The study will be entitled: "The Pharmacokinetic Study of Gabapentin in Japanese Epileptic Subjects with Renal Impairment".

Conditions

• PK Properties Of Gabapentin In Subjects With Impaired Renal Function

Interventions

Type	Name	Description
DRUG	Gabapentin	CLcr:14-5 mL/min
DRUG	Gabapentin	CLcr: 29-15 mL/min
DRUG	Gabapentin	Hemodialysis
DRUG	Gabapentin	CLcr: 29-30 mL/min

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2008-01-02
• Last updated: 2021-02-02

Locations

1 site across 1 country: Japan