An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal; Pharmacokinetics
Intervention: Gabapentin (Drug); Gabapentin (Drug); Gabapentin (Drug); Gabapentin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
Study design: Treatment, Open Label, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetics
Secondary outcome: There are no secondary outcomes for this study
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pfizer Investigational Site, Aira-gun, Aira-cho, Kagoshima-Ken, Japan
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2007
Ending date: December 2008
Last updated: June 9, 2008
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