An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

Viatris

Status and phase: Terminated; Phase 4

Conditions: PK Properties Of Gabapentin In Subjects With Impaired Renal Function

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00584779

A9451160

Details and patient eligibility

About

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.

Full description

The study was terminated on September 30, 2008 at the current study site due to reported adverse events in the study subjects (n=8). While the adverse events reported were generally consistent with the known profile of gabapentin, it was decided that the study should continue at a different study site. The pharmacokinetics of gabapentin in the subjects with renal impairment will be evaluated in a separate study with a different study number at a different site. The study will be entitled: "The Pharmacokinetic Study of Gabapentin in Japanese Epileptic Subjects with Renal Impairment".

Enrollment: 8 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 4 patient groups

1

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin

2

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin

3

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin

4

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin