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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR2964
• Date of registration: 26/06/2011
• Primary sponsor: Maastricht University Medical Center (MUMC+)
• Public title: Gabapentin 800 mg tablets, four-way crossover, fasting bioavailability study in healthy subjects.
• Scientific title: A randomized, four-way crossover, comparative bio-availability study of branded (Neurontin®) and three generic 800 mg gabapentin tablets in healthy subjects under fasting conditions. - Bioavailability of gabapentine
• Date of first enrolment: 1/9/2011
• Target sample size: 24
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2964
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Crossover; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: F. Vanmolkot

• Name: F. Vanmolkot

Key inclusion & exclusion 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: 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Antiepileptics, Bioavailability, Gabapentine

Intervention(s)

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® tablet or one of the 3 generic gabapentin tablets in a randomized order) at the beginning of each period.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

DRUM11-GABA

Source(s) of Monetary Support

Radboud University Nijmegen Medical Centre, College ter Beoordeling van Geneesmiddelen-Medicine Evaluation Board