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
Conditions
Interventions
There will be 4 periods of administration of gabapentin, each separated by one week. Each volunteer will receive a single dose of 800 mg of gabapentin after an overnight fast (either a brand Neurontin
Sponsors
Maastricht University Medical Center +
P.O. Box 5800
6202 AZ Maastricht
The Netherlands
Tel: 043 388 1766
Fax: 043 367 0916
Eligibility
Inclusion criteria
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; 2. Non-smoking (for at least 3 months) or moderately smoking, i.e. less than 10 cigarettes a day (for at least 3 months); 3. Weighing within the normal range according to accepted normal values of the Body Mass Index Chart (18-30 kg/m2); 4. In a healthy condition, as assessed by the investigator based on medical history, physical exam, vital signs, routine laboratory tests and 12-lead ECG; 5. Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using an acceptable birth control methods; 6. Voluntarily consenting to participate in the study.
Exclusion criteria
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; 2. A positive test result for HIV, hepatitis B and C; 3. In addition, history or presence of: Alcoholism or drug abuse within the past year; Hypersensitivity or idiosyncratic reaction to gabapentin or any other anti-convulsive agents; 4. Female subjects who are pregnant or lactating; 5. Subjects who have a variable, instable nutrition pattern; 6. Subjects who have donated blood within the last 2 months, or who have donated plasma within the last 14 days; 7. Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactF. Vanmolkot
P. Debyelaan 25
Outcome results
None listed