Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-29 @ 8:44 PM
Study NCT ID:
NCT00775151
Status:
COMPLETED
Last Update Posted:
2008-10-20
First Post:
2008-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Amlodipine 10mg Tablets Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-16', 'studyFirstSubmitDate': '2008-10-16', 'studyFirstSubmitQcDate': '2008-10-16', 'lastUpdatePostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bioequivalence amlodipine 10 mg tablet under fed conditions'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicalstudies.ranbaxy.com', 'label': 'Related Info'}, {'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'Related Info'}, {'url': 'http://dailymed.nlm.nih.gov/dailymed/about.cfm', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to compare the rate and extent of absorption of Ranbaxy amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one tablet dose in fed state subjects.', 'detailedDescription': 'The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on Amlodipine besylate formulations comparing Amlodipine 10mg tablets of Ranbaxy Laboratories with (Norvasc®, Pfizer Inc USA, in healthy, adult, human, subjects under fed conditions\n\nEnrolled and randomized: 40 each treatment) Drop-outs (withdrew from study): 1 Withdrawals (was dropped from study): 4 Completed: 36'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is she willing .to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra- uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the stndy?\n\n * Is s/he considered .reliable and capable of understanding his/her responsibility and role in the study.\n * Has s/he provided written informed consent?\n\nA no answer to any of the above questions indicated that the individual was ineligible for enrollment\n\nExclusion Criteria:\n\n* Does the individual have a history of allergy or hypersensitivity to amlodipine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?\n* Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety'?\n* Is she nursing?\n* Does s/he have serious psychological illness?\n* Does s/he have significant h/story (within the past year) or clinical evidence of alcohol or drug abuse? •\n* Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation?\n* Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period?\n* Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?\n* Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?\n* Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?\n\nHas s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)?"}, 'identificationModule': {'nctId': 'NCT00775151', 'briefTitle': 'Bioequivalence Study of Amlodipine 10mg Tablets Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ranbaxy Inc.'}, 'officialTitle': 'The Objective of This Study Was to Compare the Rate and Extent of Absorption of Ranbaxy Amlodipine 10 mg Tablet to That of Norvasc® 10 mg Tablet After a Single, One Tablet Dose in Fed State Subjects.', 'orgStudyIdInfo': {'id': '50366'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'amlodipine 10 mg tablet of Ranbaxy', 'interventionNames': ['Drug: amlodipine 10 mg tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Norvasc® 10 mg tablets', 'interventionNames': ['Drug: amlodipine 10 mg tablet']}], 'interventions': [{'name': 'amlodipine 10 mg tablet', 'type': 'DRUG', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'SFBC Ft. Myers, Inc.', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ranbaxy Laboratories Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Tausif Monif', 'oldOrganization': 'Ranbaxy Research Labs'}}}}