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
Outcome
Outcome not reported
Stopped: “See termination reason in detailed description.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Unknown | 100 mg | — |
| Subject | Gabapentin | Unknown | 200 mg | — |
| Subject | Gabapentin | Unknown | 400 mg | — |
| Subject | Gabapentin | Unknown | 500 mg | — |
| Subject | Gabapentin | Unknown | 1000 mg | — |