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.

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. - Comparative bio-availability study with gabapentin.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35125

Enrollment

Registered

2011-07-19

Start date

2011-09-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilepsie epilepsy neuropatic pain

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 Neurontin® or o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *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.

Exclusion criteria

Exclusion criteria: *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.

Design outcomes

Primary

Measure	Time frame
To compare the pharmacokinetic profile of gabapentin from 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).	—

Measure

Time frame

To compare the pharmacokinetic profile of gabapentin from 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 from 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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)