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

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

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.

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".

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