Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-01 @ 8:03 AM
Study NCT ID:
NCT00749359
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2008-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAXIL CR Bioequivalence Study
Sponsor:
Organization:
Raw JSON
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Safety & tolerability measures including ae reporting & vitals signs & ECGs', 'timeFrame': 'measured up to 168 hours after a single dose and throughout study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healthy volunteers', 'paroxetine'], 'conditions': ['Depressive Disorder']}, 'referencesModule': {'availIpds': [{'id': 'PCR111656', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PCR111656', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PCR111656', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PCR111656', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PCR111656', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PCR111656', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PCR111656', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}, {'url': 'https://www.gsk-clinicalstudyregister.com/study/PCR111656?search=study&search_terms=PCR111656#rs', 'label': 'Results for study PCR111656 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion:\n\nHealthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG.\n\nKey Exclusion:\n\nPositive test for drugs or alcohol. Positive for Hepatitis or HIV. Any history of psychiatric disorder or suicidal behavior. Has taken another investigational product within 30 days of the start of this study. Has been exposed to more than 4 new chemical entities in the last 12 months. Females who are pregnant or nursing. Regular consumption of alcohol; \\>14 drinks/week for men or \\>7 drinks/week for women. Heavy smokers; greater than 20 cigarettes per day.'}, 'identificationModule': {'nctId': 'NCT00749359', 'briefTitle': 'PAXIL CR Bioequivalence Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-label, Randomized, Single Dose, Two-period Crossover Study to Demonstrate Bioequivalence Between the Controlled Release Paroxetine Tablet (37.5 mg) Manufactured at Cidra and Mississauga', 'orgStudyIdInfo': {'id': 'PCR111656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'open label treatment', 'description': 'On each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1.', 'interventionNames': ['Drug: Paxil CR']}], 'interventions': [{'name': 'Paxil CR', 'type': 'DRUG', 'description': 'Paxil CR 37mg tablet manufactures at two different sites', 'armGroupLabels': ['open label treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14202', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '98418', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}