Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00406432
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2006-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2006-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-27', 'studyFirstSubmitDate': '2006-11-30', 'studyFirstSubmitQcDate': '2006-11-30', 'lastUpdatePostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pharmacokinetic parameters', 'timeFrame': 'Up to 21 days'}], 'secondaryOutcomes': [{'measure': 'safety parameters(adverse events, lab test results,vital signs,electrocardiograph)', 'timeFrame': 'Up to 21 days'}]}, 'conditionsModule': {'keywords': ['BRL029060/Paroxetine CR', 'pharmacokinetics', 'repeat dose'], 'conditions': ['Depressive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://gsk-clinicalstudyregister.com/study/PCR104075?search=study&study_ids=PCR104075#rs', 'label': 'Results for study PCR104075 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy Chinese subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 19-45 years healthy Chinese subjects\n* Body weight \\> 50 kg\n* BMI between 19-25\n* serological negative for HIV, syphilis and hepatitis B and C\n* no abnormalities in ECG\n* Female with negative pregnancy and male has no plan to have a child during and 3 months after the study.\n\nExclusion criteria:\n\n* History of chronic physical/mental disease, current disease and concomitant medication'}, 'identificationModule': {'nctId': 'NCT00406432', 'briefTitle': 'A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Steady-state Study to Assess the Pharmacokinetic Profile of Paroxetine After 14 Day Repeated Daily Dosing of the Controlled Release Paroxetine Tablet (25 mg) in Healthy Chinese Subjects', 'orgStudyIdInfo': {'id': 'PCR104075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects receiving paroxetine', 'description': 'Eligible subjects will receive single dose of paroxetine 25 milligrams controlled release formulation followed by wash-out period of 5 days. Subjects will receive multiple doses of paroxetine 25 milligrams for further 14 days.', 'interventionNames': ['Drug: Paroxetine Controlled Release Tablet']}], 'interventions': [{'name': 'Paroxetine Controlled Release Tablet', 'type': 'DRUG', 'description': 'Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams.', 'armGroupLabels': ['Subjects receiving paroxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}