Gabapentin 800 mg tablets, four-way crossover, fasting bioavailability study in healthy subjects.

Completed

Conditions: In clinical practice, generic drugs (generics) are often interchanged, whereas factual data regarding generic-generic interchangeability are lacking. Under these conditions, the so-called ‘shift’ or ‘drift’ problem that may occur when generics are interchanged may be reason for concern
while generics are exchangeable with the innovator product, generics themselves may not be, which may lead to loss of efficacy or increased toxicity. This problem may be relevant for certain drugs with a narrow therapeutic window, including anti-epileptic drugs, where seizure control may be lost or side-effects may increase when patients switch from one generic to another.

Registration Number: NL-OMON25575

Lead Sponsor: Maastricht University Medical Center +P.O. Box 58006202 AZ MaastrichtThe NetherlandsTel: 043 388 1766Fax: 043 367 0916

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

1. Male or female volunteers, 18-55 years of age;

Exclusion Criteria

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the pharmacokinetic profile of gabapentin of the Neurontin® 800 mg tablet and three generic gabapentin 800 mg tablets after single dose administration of 800 mg in healthy volunteers under fasting conditions. The main endpoints will be the 90% confidence intervals of the ratio of least-squares means of the pharmacokinetic parameters AUC0-t, AUCinf, and Cmax of two tested gabapentin products (for all combinations among the four products).

Secondary Outcome Measures

Name	Time	Method
To compare the tolerability and safety of gabapentin of the Neurontin® 800 mg tablet and three generic gabapentin 800 mg tablets after single dose administration of 800 mg in healthy volunteers under fasting conditions.