Overview
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Status:
Terminated
Terminated
Trial end date:
2010-04-01
2010-04-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Treatments:
Gabapentin
gamma-Aminobutyric Acid
Criteria
Inclusion Criteria:- Japanese epilepsy patients with renal impairment
Exclusion Criteria:
- NA