drugset / Trial / NCT00785772
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-03
- Primary completion
- 2010-04
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | 100 mg | — |
| Subject | Gabapentin | Small molecule | 200 mg | — |
| Subject | Gabapentin | Small molecule | 400 mg | — |
| Subject | Gabapentin | Small molecule | 500 mg | — |
| Subject | Gabapentin | Small molecule | 1000 mg | — |