Overview

A Relative Bioavailability Study of Gabapentin Tablets 800 mg Under Fasting Conditions

Status:
Completed
Trial end date:
2001-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 800 mg NEURONTIN® Tablets by Parke-Davis following a single oral dose (1 x 800 mg) in healthy adult volunteers under fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Actavis Inc.
Treatments:
Gabapentin
gamma-Aminobutyric Acid
Criteria
Inclusion Criteria:

- Screening Demographics: All volunteers selected for this study will be healthy men or
women 18 years of age or older at the time of dosing. The weight range will not exceed
± 15% for height and body frame as per Desirable Weights for Men -1983 Metropolitan
Height and Weight Table or as per Desirable Weights for Women -1983 Metropolitan
Height and Weight Table

- Screening Procedures: Each volunteer will complete the screening process within 28
days prior to Period I dosing. Consent documents for both the screening evaluation and
HIV antibody determination will be reviewed, discussed, and signed by each potential
participant before full implementation of screening procedures.

- Screening will include general observations, physical examination, demographics,
medical and medication history, an electrocardiogram, sitting blood pressure and heart
rate, respiratory rate and temperature. -The physical examination will include, but
may not be limited to, an evaluation of the cardiovascular, gastrointestinal,
respiratory and central nervous systems.

- The screening clinical laboratory procedures will include:

- HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential; RBC count,
platelet count

- CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin,
total bilirubin, total protein, and alkaline phosphatase;

- HIV antibody and hepatitis B surface antigen screens;

- URINALYSIS: by dipstick, microscopic examination if dipstick positive; and .

- URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines,
cannabinoids, cocaine metabolites, opiates and phencyclidine.

- SERUM PREGNANCY SCREEN (female volunteers only)

- If female and:

- of childbearing potential, is practicing an acceptable barrier method of birth
control for the duration of the study as judged by the investigator(s), such as
condoms, sponge, foams, jellies, diaphragm; intrauterine device (IUD), or
abstinence

- is postmenopausal for at least I year; or

- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy).

Exclusion Criteria:

- Volunteers with a recent history of drug or alcohol addiction or abuse.

- Volunteers with the presence of a clinically significant disorder involving the
cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
endocrine, or neurologic system(s) or psychiatric disease (as determined by the
medical investigator).

- Volunteers whose clinical laboratory test values are outside the accepted reference
range and when confirmed on re-examination are deemed to be clinically significant.

- Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive
HIV antibody screen.

- Volunteers demonstrating a positive drug abuse screen when screened for this study.

- Female volunteers demonstrating a positive pregnancy screen.

- Female volunteers who are currently breastfeeding.

- Volunteers with a history of allergic response(s) to gabapentin or related drugs.

- Volunteers with a history of clinically significant allergies including drug
allergies.

- Volunteers with a clinically significant illness during the 4 weeks prior to Period I
dosing (as determined by the medical investigator).

- Volunteers who currently use tobacco products.

- Volunteers who have taken any drug known to induce or inhibit hepatic• drug metabolism
in the 30 days prior to Period I dosing.

- Volunteers who report donating greater than 150 mL of blood within 30 days prior to
Period I dosing. All subjects will be advised not to donate blood for four weeks after
completing the study.

- Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to
Period I dosing. All subjects will be advised not to donate plasma for four weeks
after completing the study.

- Volunteers who report receiving any investigational drug within 30 days prior to
Period I dosing.

- Volunteers who report taking any systemic prescription medication in the 14 days prior
to Period I dosing, with the exception of oral contraceptives for female volunteers