Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-23 @ 5:41 AM
Study NCT ID:
NCT02965261
Status:
COMPLETED
Last Update Posted:
2016-11-16
First Post:
2016-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablet Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-14', 'studyFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-14', 'lastUpdatePostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'pre-dose to 72 hours post-dose'}, {'measure': 'AUC', 'timeFrame': 'pre-dose to 72 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': "Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.", 'detailedDescription': 'An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Fluoxetine Tablets containing Fluoxetine 20 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Sarafem® 20 mg Tablets containing Fluoxetine 20 mg (Reference , Warner Chilcott LLC, USA) in Healthy Human Volunteers Under Fasting Condition.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: male\n* Age: 18-45 years (inclusive both)\n* Volunteer with BMI of 18.5-27 (inclusive both) kg/m2 with minimum of 50 kg weight.\n* Healthy and willing to participate in the study.\n* Volunteer willing to provide written informed consent.\n* Non-smokers or smoker who smokes less than 10 cigarettes per day.\n\nExclusion Criteria:\n\n* Inability to communicate or co-operate.\n* Volunteers suffering from any chronic illness such as arthritis, asthma etc.\n* History of pre-existing bleeding disorder.\n* Clinically relevant abnormalities in the results of the laboratory screening evaluation.\n* Clinically significant abnormal ECG or Chest X-ray.\n* HIV, HCV, HBsAg positive volunteers.\n* History of significant blood loss due to any reason, including blood donation in the past 3 months.\n* Participation in any study within past 3 months,\n* History of alcohol or drug abuse.\n* History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study. Positive to Breath alcohol test.\n* Positive to breath alcohol test.\n* Volunteer found to be positive for Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.\n* Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mm Hg or more than 89 mm Hg.\n* Pulse rate less than 60/minute or more than 100/minute.\n* Oral temperature less than 95°F or more than 98.9°F.\n* Respiratory rate less than 10/minute or more than 20/minute.\n* History of allergy to the test drug or any drug chemically similar to the drug under investigation.\n* Recent History of kidney or liver dysfunction.\n* Volunteers suffering from any psychiatric (acute or chronic) disorder.\n* Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.'}, 'identificationModule': {'nctId': 'NCT02965261', 'briefTitle': "Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablet Under Fasting Conditions", 'organization': {'class': 'INDUSTRY', 'fullName': 'Torrent Pharmaceuticals Limited'}, 'officialTitle': 'An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE Study of Fluoxetine Tablets 20 mg [Torrent,India] Versus Sarafem 20 mg Tablet [ Warner Chilcott LLC, USA] in Healthy Subjects-Fasted Condition.', 'orgStudyIdInfo': {'id': 'PK-12-056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': "Torrent's Fluoxetine Tablets 20 mg", 'interventionNames': ["Drug: Torrent's Fluoxetine Tablets"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': "Warner Chilcott LLC's Sarafem® Tablet 20 mg", 'interventionNames': ['Drug: Warner Chilcott LLC Sarafem Tablets']}], 'interventions': [{'name': "Torrent's Fluoxetine Tablets", 'type': 'DRUG', 'armGroupLabels': ['Test']}, {'name': 'Warner Chilcott LLC Sarafem Tablets', 'type': 'DRUG', 'armGroupLabels': ['Reference']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torrent Pharmaceuticals Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}