A Post-Marketing Clinical Pharmakokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Impairment
Intervention: Gabapentin (Drug); Gabapentin (Drug); Gabapentin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
The primary objectives of this study are to evaluate the pharmacokinetics 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.
Clinical Details
Official title: A Post-Marketing Clinical Pharmakokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetics: measuring plasma Gabapentin concentration
Secondary outcome: Safety: adverse events, laboratory data, physical examination, blood pressure, pulse rate, and body weight
Eligibility
Minimum age: 20 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Japanese epilepsy patients with renal impairment
Exclusion Criteria:
- NA
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2010
Ending date: March 2010
Last updated: October 13, 2009
|
