Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT03517020
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Torrent Pharmaceuticals's Ltd's Nebivolol 20 mg Tablet
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': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-05-04', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'pre-dose to 8 hours post-dose'}, {'measure': 'AUC', 'timeFrame': 'pre-dose to 8 hours fasting post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': "Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic 20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were separated by a washout period of 11 days.", 'detailedDescription': 'An Open Label, Randomized, 2 -period, 2 -Treatment, 2 Sequence, Crossover, Single-dose Bioequivalence Study of Nebivolol Tablets containing Nebivolol 20 mg (Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20 mg (Reference, Forest Pharmaceuticals Inc., 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 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.\n* Healthy and willing to participate in the study.\n* Volunteer willing to adhere to the protocol requirements and 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 before entry to the study,\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.\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 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.\n* Pulse rate less than 50/minute or more than 100/minute.\n* Oral temperature less than 95°F or more than 98.6°F.\n* Respiratory rate less than 12/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': 'NCT03517020', 'briefTitle': "Bioequivalence Study of Torrent Pharmaceuticals's Ltd's Nebivolol 20 mg Tablet", 'organization': {'class': 'INDUSTRY', 'fullName': 'Torrent Pharmaceuticals Limited'}, 'officialTitle': 'An Open Label, Randomized, 2-Period, 2- Treatment, 2 -Sequence, Crossover, Single-Dose BE Study of Nebivolol 20 mg Tablet [Torrent, India]Versus Bystolic® 20 mg Tablet [ Forest Pharmaceuticals Inc., USA] in Healthy Subjects - Fasted.', 'orgStudyIdInfo': {'id': 'PK-10-150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': "Torrent's Nebivolol Tablets 20 mg", 'interventionNames': ["Drug: Torrent's Nebivolol Tablets"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': "Forest Pharmaceuticals Inc.'s Bystolic® Tablets 20 mg", 'interventionNames': ["Drug: Forest Pharmaceuticals Inc's Bystolic Tablets"]}], 'interventions': [{'name': "Torrent's Nebivolol Tablets", 'type': 'DRUG', 'armGroupLabels': ['Test']}, {'name': "Forest Pharmaceuticals Inc's Bystolic Tablets", 'type': 'DRUG', 'armGroupLabels': ['Reference']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torrent Pharmaceuticals Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}