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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2007

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".

Interventions

  • Drug: Gabapentin
    • CLcr:14-5 mL/min
  • Drug: Gabapentin
    • CLcr: 29-15 mL/min
  • Drug: Gabapentin
    • Hemodialysis
  • Drug: Gabapentin
    • CLcr: 29-30 mL/min

Arms, Groups and Cohorts

  • Experimental: 1
  • Experimental: 2
  • Experimental: 3
  • Experimental: 4

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics
    • Time Frame: dec 2008

Secondary Measures

  • There were no secondary outcomes measures for this study
    • Time Frame: dec 2008

Participating in This Clinical Trial

Inclusion Criteria

  • The subjects whose creatinine clearance is 5-59 mL/min, or hemodialysis patients. – The hemodialysis patients who enter this study is required hemodialysis for at least six weeks (the frequency is three times per week) Exclusion Criteria:

  • Renal allograft recipients

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.