Status:
TERMINATED
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Renal Impairment
Eligibility:
All Genders
20-64 years
Phase:
PHASE4
Brief 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 c...
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) ...
Eligibility Criteria
Inclusion
- Japanese epilepsy patients with renal impairment
Exclusion
- NA
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00785772
Start Date
March 1 2010
End Date
April 1 2010
Last Update
February 3 2021
Active Locations (1)
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1
Pfizer Investigational Site
Saijyo-shi, Ehime, Japan