Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-01 @ 6:47 PM
Study NCT ID:
NCT02962258
Status:
COMPLETED
Last Update Posted:
2016-11-11
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BE Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab - Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-09', 'studyFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2016-11-09', 'lastUpdatePostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Pre-dose to 72 hours after post dose'}, {'measure': 'AUC', 'timeFrame': 'Pre-dose to 72 hours after post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': "Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22 days.", 'detailedDescription': 'An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Tribenzor® 40+10+25 mg Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg (Reference , Daichi Sankyo Inc., USA) in Healthy Human Volunteers Under Fed 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 18-25 (inclusive both) kg/m2\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* Preferably Non-smokers\n\nExclusion Criteria:\n\nThe volunteers were excluded from the study based on the following criteria:\n\n* Clinically relevant abnormalities in the results of the laboratory screening evaluation.\n* Clinically significant abnormal ECG or Chest X-ray.\n* Systolic blood pressure less than 110 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.\n* Pulse rate less than 60/minute or more than 100/minute. Oral temperature less than 95°F or more than 99°F.\n* Respiratory rate less than 14/minute or more than 18/minute\n* History of allergy to the test drug or any drug chemically similar to the drug under investigation.\n* History of alcohol or drug abuse\n* Positive breath alcohol test\n* Recent history of kidney or liver dysfunction.\n* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.\n* Volunteers suffering from any chronic illness such as arthritis, asthma etc.\n* History of heart failure.\n* HIV, HCV, HBsAg positive volunteers.\n* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.\n* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.\n* Administration of any study drug in the period 0 to 3 months before entry to the study.\n* History of significant blood loss due to any reason, including blood donation in the past 3 months.\n* History of pre-existing bleeding 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.\n* Inability to communicate or co-operate.'}, 'identificationModule': {'nctId': 'NCT02962258', 'briefTitle': "BE Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab - Fed Conditions", 'organization': {'class': 'INDUSTRY', 'fullName': 'Torrent Pharmaceuticals Limited'}, 'officialTitle': 'An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of FDC of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab 40+10+25 mg [Torrent,India] Vs Tribenzor 40+10+25 mg Tablets [ Daichi,USA] in Healthy Subjects-Fed Condition.', 'orgStudyIdInfo': {'id': 'PK-10-156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': "Torrent's Olmesrtan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg", 'interventionNames': ["Drug: Torrent's Olmesartaan medoxomil, Amlodipine and Hydrochlorothiazide Tablets"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': 'Tribenzor of Daichi Sankyo Inc., USA', 'interventionNames': ['Drug: Tribenzor of Daichi Sankyo Inc. USA']}], 'interventions': [{'name': "Torrent's Olmesartaan medoxomil, Amlodipine and Hydrochlorothiazide Tablets", 'type': 'DRUG', 'description': 'oral, crossover', 'armGroupLabels': ['Test']}, {'name': 'Tribenzor of Daichi Sankyo Inc. USA', 'type': 'DRUG', 'description': 'oral, crossover', 'armGroupLabels': ['Reference']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torrent Pharmaceuticals Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}