NCT00785772

A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was used for the evidence of the dose adjustment for the patients with renal impairment, and observed plasma gabapentin concentration.

Detailed description

Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Gabapentin	100-200mg once a day
DRUG	Gabapentin	200-500mg once a day
DRUG	Gabapentin	400-1000mg (200-500 mg twice a day)

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-11-05
• Last updated: 2021-02-03
• Results posted: 2011-04-27

Locations

1 site across 1 country: Japan