Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 10:48 AM
Study NCT ID:
NCT01540734
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-20', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare bioavailability as measured by Area under the Curve in both fed and fasted states', 'timeFrame': 'Visit 1 through Visit 3 (Day 13)'}, {'measure': 'To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax', 'timeFrame': 'Visit 1 through Visit 3 (Day 13)'}], 'secondaryOutcomes': [{'measure': 'To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)', 'timeFrame': 'Visit 1 through Visit 3 (Day 13)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['paracetamol', 'pharmacokinetic'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'A single dose pharmacokinetic study investigating two paracetamol formulations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good general heatlh with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination\n\nExclusion Criteria:\n\n* Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the remainder of the study.\n* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.\n* Current (within 14 days of screening) or regular use of any prescription, over the counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.'}, 'identificationModule': {'nctId': 'NCT01540734', 'briefTitle': 'Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations', 'orgStudyIdInfo': {'id': 'A2750606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Marketed paracetamol', 'description': 'marketed formulation', 'interventionNames': ['Drug: Marketed paracetamol']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental paracetamol formulation', 'description': 'Experimental formulation', 'interventionNames': ['Drug: Experimental paracetamol formulation']}], 'interventions': [{'name': 'Marketed paracetamol', 'type': 'DRUG', 'description': 'Marketed formulation', 'armGroupLabels': ['Marketed paracetamol']}, {'name': 'Experimental paracetamol formulation', 'type': 'DRUG', 'description': 'Experimental formulation', 'armGroupLabels': ['Experimental paracetamol formulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68501', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'MDS Pharma Services NEBRASKA', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}