A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Status:
Terminated
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
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 4
Details
Lead Sponsor:
Pfizer Pfizer's Upjohn has merged with Mylan to form Viatris Inc.