Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-30 @ 5:21 PM
Study NCT ID:
NCT01000857
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2009-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male 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': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2010-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2009-10-22', 'studyFirstSubmitQcDate': '2009-10-22', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters of plasma paroxetine after 14-days repeat dosing of paroxetine CR at 25mg/day or paroxetine IR at 20mg/day', 'timeFrame': 'up to 96 hours after dosing on Day 14 of each treatment period of paroxetine CR or paroxetine IR'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability in healthy Japanese male volunteers during and after the repeat dosing period of paroxetine CR or paroxetine IR', 'timeFrame': 'During the 14-days repeat dosing period and up to 96 hours after the last dose of paroxetine CR or paroxetine IR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['controlled-release tablet', 'repeat dose', 'immediate-release tablet', 'paroxetine', 'safety', 'crossover', 'pharmacokinetics', 'steady-state', 'Japanese healthy male volunteers', 'tolerance'], 'conditions': ['Depressive Disorder']}, 'referencesModule': {'availIpds': [{'id': '112812', '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': '112812', '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': '112812', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112812', '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'}], 'seeAlsoLinks': [{'url': 'https://gsk-clinicalstudyregister.com/study/112812?search=study&search_terms=112812#rs', 'label': 'Results for study 112812 can be found on the GSK Clinical Study Register.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to compare the steady-state pharmacokinetic profile of paroxetine CR (controlled-release) at the dosage of 25mg/day using the proposed final market tablet of CR 25mg in Japan with that of standard paroxetine IR(immediate-release ) at the dosage of 20mg/day using the currently marketed tablet of IR 20mg in Japan.', 'detailedDescription': 'This study is an open, randomized, repeat dose, two-period crossover design in Japanese healthy male volunteers. This clinical trial is designed primarily to compare the steady-state pharmacokinetic profile of paroxetine CR at the dosage of 25mg /day (25mg once daily for 14 days) using the proposed final market tablet of CR 25mg in Japan with that of paroxetine IR at the dosage of 20mg/day (20mg once daily for 14 days) using the currently marketed IR 20mg tablet in Japan, by the crossover oral repeat dosing manner.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy Japanese adult males between 20 and 64 years of age inclusive\n* BMI 18.50 or higher and \\< 25.00 kg/m2, and bodyweight 50 kg or higher\n* Non-smokers\n* AST, ALT, ALP, gamma-GTP and total-bilirubin are below the upper limit of normal range\n* QTc(B) interval \\<450 msec\n* Able to attend all visits and complete the study\n* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form\n\nExclusion Criteria:\n\n* Any clinically relevant abnormality on the screening physical examination, vital signs, 12-lead ECG and/or clinical laboratory tests\n* Medical history that is not considered as eligible for inclusion in this study by the investigator\n* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones)\n* History of psychiatric disorder or suicide attempts or behaviours\n* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs\n* History of sensitivity to any of the paroxetine formulations, or components thereof\n* Positive for urine drug screening\n* Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device\n* Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication\n* History of drug or other allergy, or idiosyncrasy, excluding a pollen allergy without current symptoms\n* History of drug abuse, or current conditions of drug abuse or alcoholism\n* History of regular alcohol consumption exceeding, on average, 14 drinks/week (1 drink = 150 mL of wine or 350 mL of beer or 45 mL of 80 proof distilled spirits) within 6 months of screening\n* Use of prescription or no-prescription drugs, including vitamins, crude drug, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication\n* Unwillingness or inability to follow the procedures outlined in the protocol\n* Consumption of grapefruit or grapefruit-containing products from 7 days prior to the first dose of study medication\n* Positive for syphilis, HIV antibody and antigen, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody\n* Donation of blood in excess of 400mL within the previous 4 months or 200mL within the previous 1 month to the first dose of study medication"}, 'identificationModule': {'nctId': 'NCT01000857', 'briefTitle': 'Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Steady-state, Two-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Repeated Daily Dosing of the Controlled-release Paroxetine Tablet (25 mg) With That of the Standard Immediate-release Paroxetine Tablet (20 mg) in Healthy Japanese Male Subjects', 'orgStudyIdInfo': {'id': '112812'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open label treatment with 2-period crossover design', 'description': 'Group 1: Paroxetine CR 25 mg/day for 14 days / Paroxetine IR 20 mg/day for 14 days.\n\nGroup 2: Paroxetine IR 20 mg/day for 14 days / Paroxetine CR 25 mg/day for 14 days.,\n\nPK results will be compared between the Paroxetine CR treatment period and the Paroxetine IR treatment period.', 'interventionNames': ['Drug: Paroxetine CR and Paroxetine IR']}], 'interventions': [{'name': 'Paroxetine CR and Paroxetine IR', 'type': 'DRUG', 'description': 'Randomized, 2-period crossover repeat dosing of Paroxetine CR at 25 mg/day for 14 days and Paroxetine IR at 20 mg/day for 14 days in Japanese healthy male volunteers', 'armGroupLabels': ['Open label treatment with 2-period crossover design']}]}, 'contactsLocationsModule': {'locations': [{'zip': '108-8642', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], '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'}}}}