Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-05 @ 12:36 PM
Study NCT ID:
NCT00648960
Status:
COMPLETED
Last Update Posted:
2008-04-01
First Post:
2008-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-31', 'studyFirstSubmitDate': '2008-03-31', 'studyFirstSubmitQcDate': '2008-03-31', 'lastUpdatePostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic; The 90% confidence interval for the exponential of the difference between the Test and the Reference product for the ln-transformed parameters Cmax, AUCT and AUC∞ should be between 80 and 125%.', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mpibiostudies.com', 'label': 'Mylan Pharmaceuticals Inc. - Clinical Trial Results'}, {'url': 'http://dailymed.nlm.nih.gov/dailymed/about.cfm', 'label': 'Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use'}, {'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'Recalls, Market Withdrawals and Safety Alerts'}]}, 'descriptionModule': {'briefSummary': "The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasting conditions. Sixty-four (64) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.\n\nStatistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered under fasting conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects meeting all of the following criteria may be included in the study:\n\nAvailability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject\n\nMales or females aged from 18 to 55 years with a body mass index (BMI) greater than or equal to 19 and below 30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report\n\nClinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the CRF (laboratory tests are presented in section 7.1.3)\n\nHealthy according to the laboratory results and physical examination\n\nExclusion Criteria:\n\nSignificant history of hypersensitivity to clarithromycin, erythromycin, other macrolide antibacterial agents or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs\n\nPresence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects\n\nPresence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease\n\nFemales who are pregnant, lactating or are likely to become pregnant during the study phases\n\nFemales of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the study\n\nPositive pregnancy test before or during the study\n\nUse of the following products (astemizole, terfenadine, cisapride or pimozide) in the previous 14 days before day 1 of the study\n\nMaintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (\\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease\n\nAny clinically significant illness in the previous 28 days before day 1 of this study\n\nUse of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.)\n\nParticipation in another clinical trial in the previous 28 days before day 1 of this study\n\nDonation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study\n\nPositive urine screening of drugs of abuse (drug names are presented in section 7.1.4)\n\nPositive results to HIV, HBsAg or anti-HCV tests\n\nHistory of fainting upon blood sampling"}, 'identificationModule': {'nctId': 'NCT00648960', 'briefTitle': 'Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State', 'organization': {'class': 'UNKNOWN', 'fullName': 'MylanPharma'}, 'officialTitle': 'Single Dose Crossover Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Healthy Male and Female Volunteers / Fasting State', 'orgStudyIdInfo': {'id': 'CAI-P3-134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Clarithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Clarithromycin']}], 'interventions': [{'name': 'Clarithromycin', 'type': 'DRUG', 'description': 'Single-dose 500 mg immediate-release oral tablet', 'armGroupLabels': ['1']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'otherNames': ['Biaxin®; Biaxin® Filmtabs'], 'description': 'Single-dose 500 mg immediate-release oral dose', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H7V 4B4', 'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Algorithme Pharma', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}], 'overallOfficials': [{'name': 'Eric Sicard, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Algorithme Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genpharm ULC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Elliot Offman Director, Biopharmaceutics', 'oldOrganization': 'Genpharm ULC'}}}}