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,...
Date First Received: November 3, 2008
Last Updated: February 2, 2010
Verified by: Pfizer, February 2010
Clinical Trial Phase: Phase 4 | Start Date: February 2010
Overall Status: Enrolling by invitation
Estimated Enrollment: 10
Brief Summary
Official Title: “A Post-Marketing Clinical Pharmakokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Study Primary Completion Date: November 2010
Intervention(s) in this Clinical Trial
- Drug: Gabapentin
- CLcr:14-5 mL/min 100-200mg/day QD
- Drug: Gabapentin
- CLcr: 29-15 mL/min 200-500mg/day QD
- Drug: Gabapentin
- CLcr: 59-30 mL/min 400-100mg/day BID
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Experimental: 2
- Experimental: 3
Outcome Measures for this Clinical Trial
Primary Measures
- Pharmacokinetics: measuring plasma Gabapentin concentration
- Time Frame: Days 0, 7
Safety Issue?: No
- Time Frame: Days 0, 7
Secondary Measures
- Safety: adverse events, laboratory data, physical examination, blood pressure, pulse rate, and body weight
- Time Frame: Baseline to Day 14
Safety Issue?: No
- Time Frame: Baseline to Day 14
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Japanese epilepsy patients with renal impairment
Exclusion Criteria:
- NA
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 64 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00785772
Study ID Number: A9451169
ClinicalTrials.gov Identifier: NCT00785772
Health Authority: Japan: Ministry of Health, Labor and Welfare
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