Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00836667
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2009-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sertraline Hydrochloride 100 mg Tablets, Fed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2009-02-03', 'studyFirstSubmitQcDate': '2009-02-03', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence based on Cmax and AUC', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the rate and extent of absorption of sertraline hydrochloride 100 mg tablets (test) versus Zoloft® (reference) administered as 1 x 100 mg tablet under fed conditions.', 'detailedDescription': 'Criteria for Evaluation: FDA Bioequivalence Criteria\n\nStatistical Methods: FDA bioequivalence statistical methods'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects will be females and/or males, non-smokers, 18 years of age and older. Female subjects will be post-menopausal or surgically sterilized.\n* Post-menopausal status is defined as absence of menses for the past 12 months.\n* Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.\n\nExclusion Criteria:\n\n* Clinically significant illnesses within 4 weeks of the administration of study medication.\n* Clinically significant surgery within 4 weeks prior to the administration of the study medication.\n* Any clinically significant abnormality found during medical screening.\n* Any reason which, in the opinion of the medical sub-investigator, would preven the subject from participating in the study.\n* Abnormal laboratory tests judged clinically significant.\n* Positive urine drug screen at screening\n* Positive testing for hepatitis B, hepatitis C or HIV at screening.\n* ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHG, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.\n* Subjects with BMI ≥ 30.0.\n* History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%)\n* History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.\n* Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.\n* History of allergic reactions to sertraline or other related drugs (e.g. fluoxetine hydrochloride, fluvoxamine hydrochloride, paroxetine hydrochloride).\n* Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.\n* Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement and products containing dextromethorphan) within 7 days prior to administration of study medication, except for topical products without systemic absorption.\n* Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.\n* Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows: less than 300 mL of whole blood within 30 days or; 300 mL to 500 mL of whole blood within 45 days or; more than 500 mL of whole blood within 56 days.\n* Positive alcohol breath test at screening.\n* Subjects who have consumed food or beverages containing grapefruit (3.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.\n* Past history of bipolar affective disorder or other active psychiatric diagnosis.\n* History of seizures.\n* Subjects with a clinically significant history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.\n* Subjects who have used tobacco in any form within the 90 days preceding study drug administration.\n* Intolerance to venipuncture.\n* Breast-feeding subjects.\n* Positive urine pregnancy test at screening (performed on all females)."}, 'identificationModule': {'nctId': 'NCT00836667', 'briefTitle': 'Sertraline Hydrochloride 100 mg Tablets, Fed', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'Randomized, 2-Way Crossover, Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets and Zoloft® 100 mg Tablets Administered as 1 x 100 mg Tablet in Healthy Subjects Under Fed Conditions.', 'orgStudyIdInfo': {'id': '02071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Sertraline hydrochloride 100 mg Tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Zoloft® 100 mg Tablets']}], 'interventions': [{'name': 'Zoloft® 100 mg Tablets', 'type': 'DRUG', 'description': '1 x 100 mg, single-dose fed', 'armGroupLabels': ['2']}, {'name': 'Sertraline hydrochloride 100 mg Tablets', 'type': 'DRUG', 'description': '1 x 100 mg, single-dose fed', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GIV2K8', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Anapharm Inc.', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}], 'overallOfficials': [{'name': 'Benoit Girard, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anapharm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}}}}