Conditions: Renal Impairment
Keywords: Gabapentin Pharmacokinetics
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the pharmacokinetics (PK) 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.

Detailed description:
Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Gabapentin intervention 2: Gabapentin intervention 3: Gabapentin
Intervention descriptions: intervention 1: 100-200mg once a day intervention 2: 200-500mg once a day intervention 3: 400-1000mg (200-500 mg twice a day)

Protocol document: