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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".
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Pfizer Investigational Site
Aira-gun, Aira-cho, Kagoshima-ken, Japan
Start Date
October 1, 2007
Primary Completion Date
December 1, 2007
Completion Date
December 1, 2007
Last Updated
February 2, 2021
8
ACTUAL participants
Gabapentin
DRUG
Gabapentin
DRUG
Gabapentin
DRUG
Gabapentin
DRUG
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Data Source & Attribution
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