Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-01 @ 10:40 AM
Study NCT ID:
NCT01155895
Status:
COMPLETED
Last Update Posted:
2010-07-02
First Post:
2010-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C044946', 'term': 'benazepril'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-01', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability based on Cmax and AUC parameters', 'timeFrame': '2 Months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bioavailability', '10 mg Amlopdipine besylate /20 mg Benazepril Hydrochloride', 'Crossover'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under fasting conditions.", 'detailedDescription': "Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Laboratories, Ltd. and Novartis (Lotrel®) 10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules in Healthy Adult Male Volunteers under Fasting Conditions"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Healthy adult male volunteers of 18-55 years of age;\n\n* Weighing at least 60 kg within 15% of their ideal weights (Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company 1983)\n* Medically healthy subjects with clinically normal laboratory profiles and ECGs;\n* Voluntarily consent to participate in the study.\n\nExclusion Criteria:\n\n\\- History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.\n\n* History or presence of:\n\n * alcoholism or drug abuse within the past year;\n * hypersensitivity or idiosyncratic reaction to amlodipine or other calcium channel blockers;\n * hypersensitivity or idiosyncratic reaction to benazepril HCl, benazeprilat or other ACE inhibitors.\n * angioedema or anaphylactic reaction to any substance;\n* Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing.\n* Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing.\n* Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.\n* Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.\n* Subjects who have vomited, who have experienced diarrhea or who have undergone vigorous and prolonged exercise (without drinking) within 24 hours prior to dosing.\n* Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.\n* Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.\n* Subjects who have participated in another clinical trial within 28 days prior to the first dose.'}, 'identificationModule': {'nctId': 'NCT01155895', 'briefTitle': 'Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': 'Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of 10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules in Healthy Adult Male Volunteers Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'AA15735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amlodipine Besylate/Benazepril Hydrochloride', 'description': "10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules of Dr.Reddy's Laboratories Limited", 'interventionNames': ['Drug: Amlodipine Besylate / Benazepril Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lotrel', 'description': 'Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules) of Novartis', 'interventionNames': ['Drug: Amlodipine Besylate / Benazepril Hydrochloride']}], 'interventions': [{'name': 'Amlodipine Besylate / Benazepril Hydrochloride', 'type': 'DRUG', 'otherNames': ['Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril', 'Hydrochloride Capsules)'], 'description': '10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules', 'armGroupLabels': ['Amlodipine Besylate/Benazepril Hydrochloride', 'Lotrel']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gaetano Morelli, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MDS Pharma Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Senior Manager -Research & Development', 'oldOrganization': "Dr. Reddy's Laboratories Limited"}}}}