PK Properties Of Gabapentin In Subjects With Impaired Renal Function
Conditions
Keywords
Gabapentin Pharmacokinetics, renal impairment
Brief 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.
Interventions
DRUGGabapentin
CLcr:14-5 mL/min
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | dec 2008 |
Secondary
| Measure | Time frame |
|---|---|
| There were no secondary outcomes measures for this study | dec 2008 |
Countries
Japan
Outcome results
None listed