Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT00406003
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2006-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) 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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2006-04-26', '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': '2006-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects', 'timeFrame': 'Up to 32 days'}], 'secondaryOutcomes': [{'measure': 'To describe Safety profile of healthy subjects when dosed with paroxetine controlled release', 'timeFrame': 'Up to 32 days'}]}, 'conditionsModule': {'keywords': ['BRL029060/Paroxetine CR', 'pharmacokinetics', 'safety'], 'conditions': ['Depressive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://gsk-clinicalstudyregister.com/study/PCR104074?search=study&study_ids=PCR104074#rs', 'label': 'Results for study PCR104074 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 19-45 years healthy Chinese\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': 'NCT00406003', 'briefTitle': 'Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Open, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Dosing of Each Enteric-coated Geomatrix Control Release Tablet Strength (12.5, 25, 37.5mg) in Healthy Chinese Subjects', 'orgStudyIdInfo': {'id': 'PCR104074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects receiving treatment sequence ABC', 'description': 'Eligible subjects will receive treatment sequence ABC; A= paroxetine 12.5 milligrams, B= paroxetine 25 milligrams, and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.', 'interventionNames': ['Drug: Paroxetine controlled release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving treatment sequence BAC', 'description': 'Eligible subjects will receive treatment sequence BAC; B= paroxetine 25 milligrams, A= paroxetine 12.5 milligrams and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.', 'interventionNames': ['Drug: Paroxetine controlled release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving treatment sequence CBA', 'description': 'Eligible subjects will receive treatment sequence CBA; C= paroxetine 37.5 milligrams, B= paroxetine 25 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.', 'interventionNames': ['Drug: Paroxetine controlled release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving treatment sequence BCA', 'description': 'Eligible subjects will receive treatment sequence BCA; B= paroxetine 25 milligrams, C= paroxetine 37.5 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.', 'interventionNames': ['Drug: Paroxetine controlled release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving treatment sequence CAB', 'description': 'Eligible subjects will receive treatment sequence CAB; C= paroxetine 37.5 milligrams, A= paroxetine 12.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.', 'interventionNames': ['Drug: Paroxetine controlled release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving treatment sequence ACB', 'description': 'Eligible subjects will receive treatment sequence ACB; A= paroxetine 12.5 milligrams, C= paroxetine 37.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.', 'interventionNames': ['Drug: Paroxetine controlled release tablet']}], 'interventions': [{'name': 'Paroxetine controlled release tablet', 'type': 'DRUG', 'description': 'Paroxetine will be given as single dose, controlled release tablet with dosing strengths of 12.5, 25 and 37.5 milligrams in fasted state separated by a wash-out period of 10 days.', 'armGroupLabels': ['Subjects receiving treatment sequence ABC', 'Subjects receiving treatment sequence ACB', 'Subjects receiving treatment sequence BAC', 'Subjects receiving treatment sequence BCA', 'Subjects receiving treatment sequence CAB', 'Subjects receiving treatment sequence CBA']}]}, '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'}}}}