Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-02-11 @ 8:52 PM
Study NCT ID:
NCT01615393
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2012-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Bioavailability of Copegus and Vilona® in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-29', 'studyFirstSubmitDate': '2012-06-06', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability', 'timeFrame': '10 days'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This prospective, randomized, single-blind, cross-over study will compare the bioavailability of Copegus (ribavirin) administered as tablets and ribavirin administered as capsules in healthy volunteers. Volunteers will be randomized to receive a single dose of 400 mg of ribavirin either as a capsule or as tablets; after a washout phase volunteers will be crossed-over to the other treatment. The anticipated time on study treatment is 10 days.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult healthy volunteers, 18 to 55 years of age\n* Clinically healthy as confirmed by medical history, physical examination, electrocardiogram, thorax teleradiography and routine clinical laboratory measurements\n* Body mass index between 18 and 28 kg/m2\n* Negative testing for drugs of abuse\n\nExclusion Criteria:\n\n* History or presence of any clinically significant condition that might interfere with the pharmacokinetics of the study drugs\n* Volunteers require co-medications during the study\n* Exposure to agents known as inducers or inhibitors of hepatic enzymatic system within 30 days prior to study start\n* Having taken any medication with a clearance period of over seven half-life before study start\n* Hospitalization or significant illness 30 days before study start\n* Having received a investigational drug within 90 days prior to study start'}, 'identificationModule': {'nctId': 'NCT01615393', 'briefTitle': 'A Study to Compare the Bioavailability of Copegus and Vilona® in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Prospective, Randomized, Single-blind, Cross-over, Comparative Study for Establishing Comparative Bioavailability of Copegus vs Vilona® in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'ML28199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ribavirin capsule arm', 'interventionNames': ['Drug: ribavirin [Vilona]']}, {'type': 'EXPERIMENTAL', 'label': 'Ribavirin tablet arm', 'interventionNames': ['Drug: ribavirin [Copegus]']}], 'interventions': [{'name': 'ribavirin [Copegus]', 'type': 'DRUG', 'description': 'Single oral dose of 400 mg tablets', 'armGroupLabels': ['Ribavirin tablet arm']}, {'name': 'ribavirin [Vilona]', 'type': 'DRUG', 'description': 'Single oral dose of a 400 mg capsule', 'armGroupLabels': ['Ribavirin capsule arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58249', 'city': 'Morelia', 'country': 'Mexico', 'geoPoint': {'lat': 19.70078, 'lon': -101.18443}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}