A randomized, four-way crossover, comparative bio-availability study of branded (Neurontin®) and three generic 800 mg gabapentin labels in healthy subjects under fasting conditions.
- Conditions
- epilepsieneuropatic pain10034606epilepsy
- Registration Number
- NL-OMON35125
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
*male or female volunteer, 18-55 years of age;
*non-smoking (for at least 3 months) or moderately smoking, i.e. less than 10 cigarettes a day;
*weighing in the normal range according to accepted normal values of BMI Chart (18-30kg/m2);
*in a healthy condition, as assessed bij the investigator based on medical history, physical exam, vital signs, routine laboratiry tests and 12-lead ECG;
*females of childbearing potential should either be sexual inactive for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method;
*voluntary consenting to participate in the study.
*history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease;
*a positive test result for HIV, hepatitis B and C;
*history or presence of alcoholism or drug abuse within the past year or hypersensitivity or idiosyncratic reaction to gabapentin or any other anticonvulsive agents;
*female subjects who are pregnant or lactating;
*subjects who have a variable, instable nutrition pattern;
*subjects who have donated blood within the last 2 months, or who have donated plasma within the last 14 days;
*subjects who have participated in another clinical trial within 28 days prior to start to the first dose.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare the pharmacokinetic profile of gabapentin from the Neurontin® 800 mg<br /><br>tablet and three generic gabapentin 800 mg tablets after single dose<br /><br>administration of 800 mg in healthy volunteers under fasting conditions.<br /><br>The main endpoints will be the 90% confidence intervals of the ratio of<br /><br>least-squares means of the pharmacokinetic parameters AUC0-t, AUCinf, and Cmax<br /><br>of two tested gabapentin products (for all combinations among the four<br /><br>products). </p><br>
- Secondary Outcome Measures
Name Time Method <p>To compare the tolerability and safety of gabapentin from the Neurontin® 800 mg<br /><br>tablet and three generic gabapentin 800 mg tablets after single dose<br /><br>administration of 800 mg in healthy volunteers under fasting conditions. </p><br>