Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2025-12-28 @ 9:03 AM
Study NCT ID:
NCT01327261
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2011-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C005177', 'term': 'benserazide, levodopa drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Area Under the Curve and Peak Concentration of plasma levodopa reached after two different drug products containing levodopa + benserazide', 'timeFrame': 'Blood samples are collected up to 6 hours after dosing. (day 1)', 'description': 'In order to comply with Argentine regulation for marketing approval this study includes 24 healthy volunteers to investigate whether the relative bioavailability of the test formulation met the regulatory criterion for the assumption of bioequivalence to the branded formulation. After dosing with each formulation, 17 blood samples are taken to measure plasma levodopa concentration by HPLC. With plasma concentration values, pharmacokinetic parameters are calculated and bioequivalence assessed with WinNonLin software.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety', 'timeFrame': 'Clinical evaluation are performed up to 6 hours after dosing. (day 1)', 'description': 'Volunteers are asked about any discomfort or unusual manifestation they feel. Vital signs are recorded at each sampling time.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['levodopa', 'benserazide', 'bioequivalence', 'pharmacokinetics', 'A Single - Dose', 'Randomized- Sequence', 'Open -Label Crossover Study'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '21635995', 'type': 'DERIVED', 'citation': 'Keller GA, Czerniuk P, Bertuola R, Spatz JG, Assefi AR, Di Girolamo G. Comparative bioavailability of 2 tablet formulations of levodopa/benserazide in healthy, fasting volunteers: a single-dose, randomized-sequence, open-label crossover study. Clin Ther. 2011 Apr;33(4):500-10. doi: 10.1016/j.clinthera.2011.04.012.'}]}, 'descriptionModule': {'briefSummary': 'A group of 24 healthy volunteers receive one tablet of an association of levodopa 200 mg and benserazide 50 mg corresponding to two drug products: a test formulation (Evoser ®; Phoenix S.A.I.C. y F., Buenos Aires, Argentina) and a reference formulation (Madopar ®; Roche Pharma, Switzerland) to assess their relative bioavailability. After administration of each formulation 17 blood samples are taken and levodopa is measured by HPLC. Pharmacokinetic parameters (AUC, Tmax and Cmax) are compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Caucasian Argentinean males and females volunteers aged 21 to 50 years with a body mass index from 19 to 27 kg/m2 were enrolled in this study.\n* All volunteers provided written informed consent prior to study initiation.\n\nExclusion Criteria:\n\n* History of cardiovascular, hepatic, renal, psychiatric, neurologic, hematologic, or metabolic disease\n* Drug or alcohol abuse within 2 years before the start of the study\n* Smoking\n* HIV, hepatitis B, or hepatitis C infection\n* Consumption of any prescribed or over-the-counter drug within 2 weeks before the study or\n* Participation in a similar study within the past 6 months. Female subjects were not to be pregnant, planning to become pregnant, or breastfeeding at the time of the study, and were required to use an effective method of contraception (intrauterine device or hormonal method) throughout the study.'}, 'identificationModule': {'nctId': 'NCT01327261', 'acronym': 'PHOE10903', 'briefTitle': 'Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University of Buenos Aires'}, 'officialTitle': 'Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers: A Single- Dose Randomized- Sequence, Open -Label Crossover Study', 'orgStudyIdInfo': {'id': 'Phoenix-Evoser (PHOE 1-0903)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levodopa + benserazide (test formulation)', 'description': 'A randomized-sequence, open-label, 2-period crossover study assessing relative bioavailability of two drug products containing the association levodopa + benserazide.', 'interventionNames': ['Drug: Levodopa + benserazide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levodopa + benserazide (reference formulation)', 'interventionNames': ['Drug: Levodopa + benserazide']}], 'interventions': [{'name': 'Levodopa + benserazide', 'type': 'DRUG', 'description': 'Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water.', 'armGroupLabels': ['Levodopa + benserazide (reference formulation)', 'Levodopa + benserazide (test formulation)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Guillermo Di Girolamo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buenos Aires University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Buenos Aires', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laboratorios Phoenix S.A.I.C.y F.', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Guillermo Di Girolamo', 'oldOrganization': 'Buenos Aires University'}}}}