Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-02 @ 1:30 AM
Study NCT ID:
NCT00865059
Status:
COMPLETED
Last Update Posted:
2010-08-17
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Relative Bioavailability Study of Gabapentin Tablets 800 mg Under Non-fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2001-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-13', 'studyFirstSubmitDate': '2009-03-17', 'studyFirstSubmitQcDate': '2009-03-18', 'lastUpdatePostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate and Extend of Absorption', 'timeFrame': '60 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Gabapentin', 'Healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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 non-fasting conditions.', 'detailedDescription': 'Study Type: Interventional Study Design: Randomized, single-dose, two-way crossover study under non-fasting conditions\n\nOfficial Title: A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Non-Fasting Conditions\n\nFurther study details as provided by Actavis Elizabeth LLC:\n\nPrimary Outcome Measures:\n\nRate and Extend of Absorption'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 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.\n* 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.\n* The screening clinical laboratory procedures will include:\n\n * HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential; RBC count, platelet count\n * CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase\n * HIV antibody and hepatitis B surface antigen screens\n * URINALYSIS: by dipstick, microscopic examination if dipstick positive\n * URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.\n * SERUM PREGNANCY SCREEN (female volunteers only)\n* If female and:\n\n * 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\n * is postmenopausal for at least I year; or\n * is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).\n\nExclusion Criteria:\n\n* Volunteers with a recent history of drug or alcohol addiction or abuse.\n* 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).\n* Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.\n* Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.\n* Volunteers demonstrating a positive drug abuse screen when screened for this study.\n* Female volunteers demonstrating a positive pregnancy screen.\n* Female volunteers who are currently breastfeeding.\n* Volunteers with a history of allergic response(s) to gabapentin or related drugs.\n* Volunteers with a history of clinically significant allergies including drug allergies.\n* Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the medical investigator).\n* Volunteers who currently use tobacco products.\n* Volunteers who have taken any drug known to induce or inhibit hepatic• drug metabolism in the 30 days prior to Period I dosing.\n* 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.\n* 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.\n* Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.\n* 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'}, 'identificationModule': {'nctId': 'NCT00865059', 'briefTitle': 'A Relative Bioavailability Study of Gabapentin Tablets 800 mg Under Non-fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actavis Inc.'}, 'officialTitle': 'A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Non-Fasting Conditions', 'orgStudyIdInfo': {'id': 'R01-080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Gabapentin 800 mg Tablets, single dose', 'interventionNames': ['Drug: Gabapentin 800 mg Tablets, single dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'NEURONTIN® 800 mg Tablets, single dose', 'interventionNames': ['Drug: NEURONTIN® 800 mg Tablets, single dose']}], 'interventions': [{'name': 'Gabapentin 800 mg Tablets, single dose', 'type': 'DRUG', 'otherNames': ['Gabapentin'], 'description': 'A: Experimental Subjects received Purepac formulated products under non-fasting conditions', 'armGroupLabels': ['A']}, {'name': 'NEURONTIN® 800 mg Tablets, single dose', 'type': 'DRUG', 'otherNames': ['Gabapentin'], 'description': 'B: Active comparator Subjects received Parke-Davis formulated products under non-fasting conditions', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58102', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'PRACS Institute, Ltd.', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}], 'overallOfficials': [{'name': 'James D. Carlson,, Pharm.D,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PRACS Institute, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actavis Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Meena Venugopal, Director, Clinical R&D', 'oldOrganization': 'Actavis Inc'}}}}