A Relative Bioavailability Study of Gabapentin Tablets 800 mg Under Fasting Conditions
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Healthy |
| Intervention | Drug: Gabapentin 800 mg Tablets, single dose Drug: NEURONTIN® 800 mg Tablets, single dose |
| Phase | Phase 1 |
| Sponsor | Actavis Inc. |
| Responsible Party | Actavis Inc. |
| ClinicalTrials.gov Identifier | NCT00865423 |
| First Received | March 17, 2009 |
| Last Updated | August 13, 2010 |
| Last verified | August 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 17, 2009 |
|---|---|
| Last Updated Date | August 13, 2010 |
| Start Date | February 2001 |
| Estimated Primary Completion Date | March 2001 |
| Current Primary Outcome Measures | Rate and Extend of Absorption [Time Frame: 60 hours] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Relative Bioavailability Study of Gabapentin Tablets 800 mg Under Fasting Conditions |
|---|---|
| Official Title | A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Fasting Conditions |
| Brief 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. |
| Detailed Description | Study Type: Interventional Study Design: Randomized, single-dose, two-way crossover design under fasting conditions Official Title: A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Fasting Conditions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label |
| Condition | Healthy |
| Intervention | Drug: Gabapentin 800 mg Tablets, single dose A: Experimental Subjects received Purepac formulated products under fasting conditions Other Names: GabapentinDrug: NEURONTIN® 800 mg Tablets, single dose B: Active comparator Subjects received Parke-Davis formulated products under fasting conditions Other Names: Gabapentin |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 28 |
| Estimated Completion Date | March 2001 |
| Estimated Primary Completion Date | February 2001 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00865423 |
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| Other Study ID Numbers | R01-079 |
| Has Data Monitoring Committee | No |
| Information Provided By | Actavis Inc. |
| Study Sponsor | Actavis Inc. |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: James D. Carlson,, Pharm.D, PRACS Institute, Ltd. |
| Verification Date | August 2010 |
Locations[ + expand ][ + ]
| PRACS Institute, Ltd. | Fargo, North Dakota, United States, 58102 |
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