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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00785772 |
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.
Condition | Intervention | Phase |
---|---|---|
Renal Impairment |
Drug: Gabapentin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Post-Marketing Clinical Pharmakokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment |
Estimated Enrollment: | 10 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Gabapentin
CLcr:14-5 mL/min 100-200mg/day QD
|
2: Experimental |
Drug: Gabapentin
CLcr: 29-15 mL/min 200-500mg/day QD
|
3: Experimental |
Drug: Gabapentin
CLcr: 59-30 mL/min 400-100mg/day BID
|
Ages Eligible for Study: | 20 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A9451169 |
Study First Received: | November 3, 2008 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00785772 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Gabapentin, Pharmacokinetics |
Excitatory Amino Acids Calcium, Dietary Gabapentin Epilepsy |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Cardiovascular Agents |
Antimanic Agents Pharmacologic Actions Membrane Transport Modulators Sensory System Agents Therapeutic Uses Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |